Ifosfamide With or Without O(6)-Benzylguanine in Treating Patients With Unresectable, Metastatic Solid Tumors

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase I trial is studying the side effects and best dose of O(6)-benzylguanine when given together with ifosfamide and to see how well it works compared to ifosfamide alone in treating patients with unresectable metastatic solid tumors. Drugs used in chemotherapy, such as ifosfamide and O(6)-benzylguanine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining ifosfamide with O(6)-benzylguanine may kill more tumor cells

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Ifosfamide; Isophosphamide mustard; O(6)-benzylguanine

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor

• Unresectable, metastatic disease

• No primary tumors

• Eligible for high-dose ifosfamide-based therapy

• No known brain metastases

• Performance status - ECOG 0-1

• Performance status - Karnofsky 70-100%

• More than 12 weeks

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• AST and ALT ≤ 2.5 times upper limit of normal

• Bilirubin normal

• Creatinine normal

• Creatinine clearance ≥ 60 mL/min

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 4 weeks after study participation

• No history of allergic reaction attributed to compounds of similar chemical or biological composition to O6-benzylguanine or other study agents

• No concurrent uncontrolled illness

• No active or ongoing infection

• No psychiatric illness or social situation that would preclude study compliance

• More than 24 hours since prior colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF])

• No prior hematopoietic stem cell transplantation

• No concurrent pegfilgrastim

• No concurrent immunotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No other concurrent chemotherapy

• No concurrent hormonal therapy

• More than 4 weeks since prior radiotherapy and recovered

• No concurrent therapeutic radiotherapy

• More than 4 weeks since prior anticancer therapy

• No more than 2 prior cytotoxic regimens

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent anticancer agents or therapies

• No other concurrent investigational agents