External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases

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

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether external-beam radiation therapy is more effective with or without indinavir and ritonavir in treating patients with brain metastases.

PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to see how well it works compared to external-beam radiation therapy given together with indinavir and ritonavir in treating patients with brain metastases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncology Institute of Southern Switzerland
• Treatments: Indinavir; Ritonavir

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic cancer with brain metastases

• Biopsy of brain metastases is not required

• All cancer types allowed, except for the following:

• Prostatic adenocarcinoma

• Sarcoma

• Melanoma

• Germ cell carcinoma,

• Small-cell lung cancer

• Measurable disease by MRI of the brain

• Not requiring immediate surgical decompression (may qualify after surgery, if remaining measurable brain lesions)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2 (corresponds to recursive partitioning analysis groups I or II)

• Life expectancy > 4 months

• Able to understand the aim of trial and to comply with follow-up

• No HIV seropositivity

PRIOR CONCURRENT THERAPY:

• Prior dexamethasone allowed provided it is tapered before initiation of study radiotherapy

• Not requiring cytotoxic treatment within 3 months after study radiotherapy

• At least 1 week since prior and no concurrent phenytoin