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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003567 |
RATIONALE: Gene therapy may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy together with chemotherapy in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
Brain and Central Nervous System Tumors Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: O6-benzylguanine Drug: carmustine Drug: filgrastim Drug: sargramostim Drug: temozolomide Drug: therapeutic autologous lymphocytes Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase I |
MedlinePlus related topics: | Cancer Lymphoma |
ChemIDplus related topics: | Filgrastim Carmustine Temozolomide Sargramostim Granulocyte-macrophage colony-stimulating factor O(6)-Benzylguanine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Mutant MGMT Gene Transfer Into Human Hematopoietic Progenitors to Protect Hematopoiesis During O6-Benzylguanine (BG, NSC 637037) and Carmustine Followed by Temozolomide Therapy of Advanced Solid Tumors |
Estimated Enrollment: | 18 |
Study Start Date: | May 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of CD34 stem cells and carmustine.
After a negative bone marrow sampling, patients receive sargramostim (GM-CSF) and filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days). Peripheral blood progenitor cells are collected 24 hours after the last dose of growth factor injection on day 5 and also on day 6, if necessary. The CD34 positive stem cells are then infected by the retroviral mutant MGMT-G156A ex vivo.
Patients receive O6-benzylguanine (BG) IV over 1 hour followed by carmustine IV over 1 hour every 6 weeks for 5 courses, assuming recovery of peripheral blood counts. Approximately 72 hours after the end of the first course of chemotherapy, patients receive reinfusion of retrovirally-transduced hematopoietic stem cells over 5-10 minutes. Four weeks after the completion of BG and carmustine, patients receive BG IV over 1 hour followed by temozolomide IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity provided other phase II studies indicate the safety of more than 5 courses.
Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine.
Patients are followed monthly for 2 months, every 4 months for 8 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically confirmed diseases for which no curative surgical, radiotherapy, or chemotherapy programs are available and standard therapy offers, at best, a modest clinical benefit
No bone marrow involvement
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Ohio | |||||
Case Comprehensive Cancer Center | |||||
Cleveland, Ohio, United States, 44106-5065 |
Case Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Stanton L. Gerson, MD | Case Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066633, CASE-CWRU-2Y97, NCI-T97-0060, CASE-2Y97 |
First Received: | November 1, 1999 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003567 |
Health Authority: | United States: Federal Government |
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