Clinical trial · Interventional
Gene Therapy and Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| in vitro-treated peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Gene transfer expression
- timeFrame
- measured at days 28, 56, 84, and 112, and then every 3 months for 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 * Solid tumors * Gliomas * Non-Hodgkin's lymphoma * Primary and metastatic CNS malignancies are eligible * Evaluable or measurable disease * CD34 count at least 2.0 cells/μL * No bone marrow involvement * Histologically negative bone marrow biopsy PATIENT CHARACTERISTICS: Age: * 18 to 70 Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8.5 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST and ALT less than 2.5 times normal * Prothrombin time less than 1.2 times normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No acute cardiac disease by EKG Pulmonary: * No symptomatic pulmonary disease Other: * HIV negative * No other severe comorbid conditions * Not pregnant or nursing * Fertile patients must use effective contraception during and for 2 months after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * No prior hematopoietic stem cell transplantation Chemotherapy: * No prior high-dose chemotherapy * Prior adjuvant chemotherapy allowed Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to 25% or more of bone marrow Surgery: * Not specified Other: * At least 4 weeks since prior myelosuppressive therapy
References
Publications (0)
Data not yet available