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COL-3 in Treating Patients With HIV-Related Kaposi's Sarcoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: AIDS Associated Malignancies Clinical Trials Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020683
  Purpose

RATIONALE: COL-3 may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposi's sarcoma.


Condition Intervention Phase
Sarcoma
Drug: COL-3
Phase II

MedlinePlus related topics: AIDS Cancer Kaposi's Sarcoma Soft Tissue Sarcoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2001
Detailed Description:

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.

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.

PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 1.75 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Hemoglobin at least 8.0 g/dL
  • Absolute neutrophil count at least 750/mm^3
  • Platelet count at least 75,000/mm^3
  • 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

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:

  • Not specified

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020683

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
AIDS Associated Malignancies Clinical Trials Consortium
Investigators
Study Chair: Bruce J. Dezube, MD Beth Israel Deaconess Medical Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000068703, AMC-027
Study First Received: July 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00020683  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma

Study placed in the following topic categories:
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
HIV Infections
Malignant mesenchymal tumor
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Sarcoma
DNA Virus Infections
Soft tissue sarcomas
Recurrence
Herpesviridae Infections

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on January 14, 2009