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Phase II Randomized Study of COL-3 in Patients With HIV-Related Kaposi's Sarcoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
COL-3 in Treating Patients With HIV-Related Kaposi's Sarcoma
Basic Trial Information
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Type
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Status
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Age
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Protocol IDs
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Phase II
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Treatment
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Closed
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18 and over
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NCI
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AMC-027 NCT00020683, AMC-027
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Objectives - Compare the tumor response rate and duration of response in patients with HIV-related Kaposi's sarcoma treated with 2 different doses of COL-3.
- Determine the biologic activity of this drug by measuring the percent of apoptotic cells in tumor biopsies of these patients before and after study therapy.
- Determine the effect of this drug on the serum levels of matrix metalloproteinase (MMP)-2 and MMP-9 in these patients.
- Compare the safety and toxicity of these regimens in these patients.
- Evaluate the quality of life of patients treated with these regimens.
- Evaluate the relationship between clinical response and quantitative measures of Kaposi's sarcoma-associated herpes virus/human herpes virus-8 and HIV viral load in patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically proven Kaposi's sarcoma (KS) involving the skin, lymph
nodes,
oral cavity, gastrointestinal (GI) tract, and/or lungs
- GI or pulmonary involvement must be asymptomatic or
minimally symptomatic
- At least 5 measurable, cutaneous lesions that can be used as indicator
lesions
- HIV positive by ELISA, Western Blot, or other federally approved,
licensed HIV test
Prior/Concurrent Therapy:
Biologic therapy: - At least 4 weeks since prior blood products
- At least 2 weeks since prior filgrastim (G-CSF) or epoetin
alfa
Chemotherapy: - At least 3 weeks since prior antineoplastic treatment for KS
and recovered
- No concurrent systemic chemotherapy for KS
- No concurrent systemic chemotherapy for other
neoplasia
Endocrine therapy: - Concurrent oral contraceptives, megestrol, or testosterone
allowed
Radiotherapy: - No prior radiotherapy to indicator lesions
- No concurrent radiotherapy for KS
Surgery: Other: - No prior local therapy to any KS indicator lesion unless there
is clear evidence of progression
- At least 2 weeks since prior acute treatment for infection or
other serious medical illness
- Prior highly active antiretroviral therapy (HAART)
allowed
- Concurrent HAART allowed if on optimal, stable regimen for a
minimum of 4 weeks before study
- Concurrent antipyretics, analgesics, allergy medications,
antidepressants, or sleep medications allowed
- Concurrent vitamins, acupuncture, or visual techniques
allowed
- No other concurrent investigational drugs
- No other concurrent therapy for KS
- No concurrent rifampin, phenytoin, or phenobarbital
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Hemoglobin at least 8.0 g/dL
- Absolute neutrophil count at least 750/mm3
- Platelet count at least 75,000/mm3
- No prior noniatrogenic bleeding disorder
Hepatic: - AST and ALT no greater than 2.5 times upper limit of
normal
- Total bilirubin normal (less than 3.5 mg/dL if elevation
secondary to indinavir, and direct bilirubin normal)
- PT and PTT less than 1.2 times normal
Renal: - Creatinine no greater than 1.5 mg/dL
OR - Creatinine clearance greater than 60 mL/min
Cardiovascular: - No evidence of prior myocardial infarction or cardiac
ischemia
Other: - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and
for 3 months after study
- No active opportunistic infection
Expected Enrollment A total of 70 patients (35 per treatment arm) will be accrued for this study
within 1.75 years. Outline This is a randomized, open-label, multicenter study. Patients are
randomized to 1 of 2 treatment arms. - Arm I: Patients receive low-dose oral COL-3 once daily.
- Arm II: Patients receive high-dose oral COL-3 once daily.
Treatment on both arms continues in the absence
of disease progression or unacceptable toxicity. Quality of life is assessed. Patients are followed for at least 1 month. Published ResultsDezube BJ, Krown SE, Lee JY, et al.: Randomized phase II trial of matrix metalloproteinase inhibitor COL-3 in AIDS-related Kaposi's sarcoma: an AIDS Malignancy Consortium Study. J Clin Oncol 24 (9): 1389-94, 2006.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations AIDS Associated Malignancies Clinical Trials Consortium | | | Bruce Dezube, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Phase II Trial of COL-3 in Patients with HIV Related Kaposi's Sarcoma | | Trial Start Date | | 2001-04-30 | | Registered in ClinicalTrials.gov | | NCT00020683 | | Date Submitted to PDQ | | 2001-05-03 | | Information Last Verified | | 2002-08-30 | | NCI Grant/Contract Number | | U01-CA70019 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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