Gene Therapy and Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

• Status: Terminated
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine; Dacarbazine; Lenograstim; O(6)-benzylguanine; Sargramostim; Temozolomide

Criteria

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