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Terminated Phase 1 Interventional

Study of Immunotoxin, MR1-1

NCT01009866
Conditions
Supratentorial Malignant Brain Tumor
Interventions
MR1-1
Biological
Lead sponsor
Darell D. Bigner, MD, PhD
Other
Eligibility
18 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2012
U.S. locations
1
States / cities
Durham, North Carolina
Conditions
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Kidney Cancer, Leukemia, Liver Cancer, Neuroblastoma, Ovarian Cancer, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
ixabepilone
Drug
Lead sponsor
National Institutes of Health Clinical Center (CC)
NIH
Eligibility
2 Years to 21 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2010
U.S. locations
2
States / cities
Washington D.C., District of Columbia • Bethesda, Maryland
Conditions
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma, Recurrent Ewing Sarcoma, Recurrent Glioma, Recurrent Hepatoblastoma, Recurrent Kidney Wilms Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Glioma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma
Interventions
Laboratory Biomarker Analysis, Palbociclib, Pharmacological Study
Other · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
12 Months to 21 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
115
States / cities
Birmingham, Alabama • Anchorage, Alaska • Mesa, Arizona + 93 more
Conditions
Glioblastoma Multiforme, Glioma, Gliosarcoma, Malignant Brain Tumor, Ependymoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma, Primary CNS Tumor
Interventions
Indoximod, Temozolomide, Conformal Radiation, Cyclophosphamide, Etoposide
Drug · Radiation
Lead sponsor
NewLink Genetics Corporation
Industry
Eligibility
3 Years to 21 Years
Enrollment
81 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
5
States / cities
Aurora, Colorado • Orlando, Florida • Atlanta, Georgia + 2 more
Conditions
Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Meningioma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Central Nervous System Germ Cell Tumor, Adult Choroid Plexus Tumor, Adult Diffuse Astrocytoma, Adult Ependymoma, Adult Grade II Meningioma, Adult Grade III Meningioma, Adult Malignant Hemangiopericytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Papillary Meningioma, Adult Pineocytoma, Malignant Neoplasm, Meningeal Melanocytoma, Radiation Toxicity, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Adult Brain Tumor, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage I Adenoid Cystic Carcinoma of the Oral Cavity, Stage I Basal Cell Carcinoma of the Lip, Stage I Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage I Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage I Lymphoepithelioma of the Nasopharynx, Stage I Lymphoepithelioma of the Oropharynx, Stage I Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage I Mucoepidermoid Carcinoma of the Oral Cavity, Stage I Salivary Gland Cancer, Stage I Squamous Cell Carcinoma of the Hypopharynx, Stage I Squamous Cell Carcinoma of the Larynx, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Nasopharynx, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage I Verrucous Carcinoma of the Larynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage III Adenoid Cystic Carcinoma of the Oral Cavity, Stage III Basal Cell Carcinoma of the Lip, Stage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage III Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage III Lymphoepithelioma of the Nasopharynx, Stage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage III Mucoepidermoid Carcinoma of the Oral Cavity, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Basal Cell Carcinoma of the Lip, Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage IV Lymphoepithelioma of the Nasopharynx, Stage IV Lymphoepithelioma of the Oropharynx, Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage IV Mucoepidermoid Carcinoma of the Oral Cavity, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity
Interventions
bevacizumab, placebo, magnetic resonance imaging, quality-of-life assessment
Drug · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Houston, Texas
Conditions
Brain and Central Nervous System Tumors, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Interventions
carboplatin, tamoxifen citrate, topotecan hydrochloride, pharmacological study
Drug · Other
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2007
U.S. locations
1
States / cities
Duarte, California
Conditions
Brain and Central Nervous System Tumors, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
filgrastim, exatecan mesylate
Biological · Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
Up to 21 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2004
U.S. locations
4
States / cities
New York, New York • Memphis, Tennessee • Dallas, Texas + 1 more
Conditions
Brain and Central Nervous System Tumors
Interventions
conventional surgery, iodine I 131 monoclonal antibody 81C6, radiation therapy
Procedure · Radiation
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1997 – 2007
U.S. locations
1
States / cities
Durham, North Carolina
Conditions
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Leukemia, Lymphoma, Metastatic Cancer, Retinoblastoma, Sarcoma
Interventions
busulfan
Drug
Lead sponsor
Pediatric Brain Tumor Consortium
Network
Eligibility
3 Years to 21 Years
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2000
U.S. locations
8
States / cities
San Francisco, California • Washington D.C., District of Columbia • Boston, Massachusetts + 5 more
Conditions
Brain and Central Nervous System Tumors
Interventions
temozolomide, protein expression analysis, reverse transcriptase-polymerase chain reaction, diagnostic laboratory biomarker analysis, immunoenzyme technique
Drug · Genetic · Other
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years to 120 Years
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2013
U.S. locations
1
States / cities
New York, New York
Conditions
Anaplastic Astrocytoma, Anaplastic Ependymoma, Anaplastic Ganglioglioma, Anaplastic Meningioma, Anaplastic Oligodendroglioma, Pleomorphic Xanthoastrocytoma, Anaplastic, Atypical Teratoid/Rhabdoid Tumor, Brain Cancer, Brain Tumor, Central Nervous System Neoplasms, Choroid Plexus Carcinoma, CNS Embryonal Tumor With Rhabdoid Features, Ganglioneuroblastoma of Central Nervous System, CNS Tumor, Embryonal Tumor of CNS, Ependymoma, Glioblastoma, Glioma, Glioma, Malignant, Medulloblastoma, Medulloblastoma; Unspecified Site, Medulloepithelioma, Neuroepithelial Tumor, Neoplasms, Neoplasms, Neuroepithelial, Papillary Tumor of the Pineal Region (High-grade Only), Pediatric Brain Tumor, Pineal Parenchymal Tumor of Intermediate Differentiation (High-grade Only), Pineoblastoma, Primitive Neuroectodermal Tumor, Recurrent Medulloblastoma, Refractory Brain Tumor, Neuroblastoma. CNS, Glioblastoma, IDH-mutant, Glioblastoma, IDH-wildtype, Medulloblastoma, Group 3, Medulloblastoma, Group 4, Glioma, High Grade, Neuroepithelial Tumor, High Grade, Medulloblastoma, SHH-activated and TP53 Mutant, Medulloblastoma, SHH-activated and TP53 Wildtype, Medulloblastoma, Chromosome 9q Loss, Medulloblastoma, Non-WNT Non-SHH, NOS, Medulloblastoma, Non-WNT/Non-SHH, Medulloblastoma, PTCH1 Mutation, Medulloblastoma, WNT-activated, Ependymoma, Recurrent, Glioma, Recurrent High Grade, Glioma, Recurrent Malignant, Embryonal Tumor, NOS, Glioma, Diffuse Midline, H3K27M-mutant, Embryonal Tumor With Multilayered Rosettes (ETMR), Ependymoma, NOS, WHO Grade III, Ependymoma, NOS, WHO Grade II, Medulloblastoma, G3/G4, Ependymoma, RELA Fusion Positive
Interventions
Gemcitabine, ribociclib, sonidegib, trametinib, filgrastim
Drug · Biological
Lead sponsor
St. Jude Children's Research Hospital
Other
Eligibility
1 Year to 39 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Memphis, Tennessee
Conditions
Cancer
Interventions
docetaxel, thalidomide
Drug
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2006
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Stage IV Melanoma
Interventions
recombinant interferon alfa-2b, cisplatin, sodium stibogluconate, dacarbazine, vinblastine
Biological · Drug
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2012
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Brain and Central Nervous System Tumors
Interventions
carmustine, conventional surgery
Drug · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1996
U.S. locations
9
States / cities
Birmingham, Alabama • Tampa, Florida • Atlanta, Georgia + 6 more
Conditions
Brain and Central Nervous System Tumors
Interventions
iodine I 131 monoclonal antibody 81C6
Radiation
Lead sponsor
Duke University
Other
Eligibility
3 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1991 – 2001
U.S. locations
1
States / cities
Durham, North Carolina
Conditions
Malignant Solid Neoplasm, Recurrent Adrenal Gland Pheochromocytoma, Recurrent Ectomesenchymoma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Kidney Wilms Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Melanoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdoid Tumor of the Kidney, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Thyroid Gland Carcinoma, Recurrent WHO Grade 2 Glioma, Refractory Adrenal Gland Pheochromocytoma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Melanoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdoid Tumor of the Kidney, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory Thyroid Gland Carcinoma, Refractory WHO Grade 2 Glioma
Interventions
Tipifarnib
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
12 Months to 21 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
171
States / cities
Birmingham, Alabama • Anchorage, Alaska • Mesa, Arizona + 129 more
Conditions
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Kidney Cancer, Liver Cancer, Neuroblastoma, Ovarian Cancer, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
O6-benzylguanine, temozolomide
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
Up to 21 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2000
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Central Nervous System Sarcoma, Ependymoma, Glioma, Malignant Intracranial Germ Cell Tumor, Medulloblastoma, Pineoblastoma, Primary Central Nervous System Neoplasm
Interventions
Placebo Administration, Questionnaire Administration, Wound Dressing Material
Other · Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
2 Years to 17 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2020
U.S. locations
1
States / cities
Houston, Texas
Conditions
Brain and Central Nervous System Tumors, Metastatic Cancer, Radiation Toxicity
Interventions
Questionnaire
Other
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
76 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2012
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Brain and Central Nervous System Tumors
Interventions
temozolomide 60 mg x 21 days, temozolomide 75 mg x 21 days, ABT-888 20 mg x 21 days, ABT-888 40 mg x 21 days, Temozolomide 150 mg x 5 days, ABT-888 40 mg x 5 days
Drug
Lead sponsor
Radiation Therapy Oncology Group
Network
Eligibility
18 Years to 120 Years
Enrollment
257 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2016
U.S. locations
17
States / cities
La Jolla, California • Los Angeles, California • Honolulu, Hawaii + 11 more
Conditions
Anaplastic Astrocytoma, Anaplastic Ependymoma, Astrocytoma, Grade II, Ependymoma, Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma, Oligodendroglioma, Brainstem Tumors
Interventions
imetelstat sodium
Drug
Lead sponsor
Pediatric Brain Tumor Consortium
Network
Eligibility
12 Months to 21 Years
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
11
States / cities
Los Angeles, California • Palo Alto, California • Washington D.C., District of Columbia + 8 more
Conditions
Glioblastoma Multiforme, Astrocytoma, Grade III, Anaplastic Ependymoma, Clear Cell Ependymoma, Ependymoma
Interventions
Heat Shock Protein Peptide Complex-96 (HSPPC-96), Tumor Resection, Radiation
Biological · Procedure · Radiation
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Eligibility
3 Years to 21 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
1
States / cities
Chicago, Illinois
Conditions
Anaplastic Astrocytoma, Anaplastic Ependymoma, Anaplastic Oligodendroglioma, Gliosarcoma, Mixed Glioma, Recurrent Adult Brain Neoplasm, Recurrent Glioblastoma
Interventions
Laboratory Biomarker Analysis, Lapatinib, Lapatinib Ditosylate, Pharmacological Study, Therapeutic Conventional Surgery
Other · Drug · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2024
U.S. locations
12
States / cities
Los Angeles, California • Baltimore, Maryland • Boston, Massachusetts + 9 more
Conditions
Brain Tumors, Spinal Cord Tumors
Interventions
Temozolomide, Lapatinib
Drug
Lead sponsor
National Institutes of Health Clinical Center (CC)
NIH
Eligibility
18 Years and older
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
6
States / cities
San Francisco, California • Boston, Massachusetts • New York, New York + 3 more