A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma

Roche

Status and phase: Completed; Phase 2

Conditions: Sarcoma, Kaposi; HIV Infections

Treatments: Drug: Ro 24-7429

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002314

128A

Details and patient eligibility

About

To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 24-7429 in this patient population. To explore relationships between exposure to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• HIV seropositivity.
• Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and measurable disease.
• No active opportunistic infection. NOTE:
• Patients with CD4 count >= 200 cells/mm3 must have no prior opportunistic infection, as well as no active opportunistic infection.
• Life expectancy of at least 24 weeks.
• Stable weight (+/- 2 kg) by 28 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer).
• Known or suspected hypersensitivity to benzodiazepines.
• Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease as determined by the investigator.
• Ongoing diarrhea (> two liquid stools per day).
• Grade 2 or worse signs and symptoms of AIDS Dementia Complex.
• Alteration of mental status that may interfere with study compliance.

Concurrent Medication:

Excluded:

• AZT, ddI, or ddC.
• Experimental antiretrovirals.
• Biologic response modifiers or immunomodulating agents (e.g., interferon).
• Colony stimulating factors (erythropoietin, GM-CSF, G-CSF).
• Ganciclovir.
• Foscarnet.
• H-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine).
• Omeprazole.
• Benzodiazepines.
• Any other investigational compound.
• Ongoing systemic treatment with corticosteroids (other than replacement therapy for adrenal insufficiency or short-term therapy of no more than 28 days for bronchial asthma).
• Cytotoxic chemotherapy (systemic and local).
• Drugs known to cause systemic toxicity, if avoidable (e.g., myelosuppressive, hepatotoxic, nephrotoxic, or neurotoxic drugs).
• Paromomycin sulfate.
• Chronic suppressive therapy for CMV and/or MAI.

Patients with the following prior condition are excluded:

History of serious adverse reactions to benzodiazepines.

Prior Medication:

Excluded:

• Interferons or immune modulators within 4 weeks prior to study entry.
• Prior systemic cytotoxic chemotherapy (patients with CD4 counts >= 200 cells/mm3 only).
• Benzodiazepines within 14 days prior to study entry.
• Intralesional chemotherapy for Kaposi's sarcoma within 2 weeks prior to study entry.
• Therapy with antiretroviral drugs (including AZT, ddI, ddC, d4T) or investigational drugs within 14 days prior to study entry.

Localized radiotherapy. Radiotherapy (other than localized). Active drug or alcohol abuse.