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A Randomized Phase II Trial to Determine the Safety, Tolerance, and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With Kaposi's Sarcoma


Phase 2
12 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

A Randomized Phase II Trial to Determine the Safety, Tolerance, and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With Kaposi's Sarcoma


Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and
suppression of HIV in some patients. Although various trials using IFN-alpha in combination
with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor
activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia)
of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this
drug may be better tolerated than zidovudine when combined with IFN-alpha.

Up to 90 patients are randomized to receive either low or high doses of IFN-alpha (1 or 10
million Units/day) in combination with a fixed dose of ddI. Fourteen patients are initially
entered at each dose level. If no objective antitumor responses are observed among the first
14 patients at a given dose, no further patients are entered on that treatment arm. If one
or more antitumor responses are seen at a given dose, up to 45 patients may be entered on
that treatment arm. Patients must complete at least 4 weeks of study therapy to be
considered evaluable for tumor response. Treatment is continued until tumor progression or
unacceptable toxicity occurs. PER AMENDMENT 9/19/96: NOTE - After 16 weeks of treatment
subjects may receive any FDA approved antiretroviral drug regimen in addition to or in
place of ddI.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Chemoprophylaxis for candidiasis and herpes simplex.

- Up to 14 days of metronidazole.

- Recombinant erythropoietin.

- G-CSF (for severe cases of neutropenia).

- Isoniazid for treatment of TB if given in conjunction with pyridoxine.

Required in patients with CD4 counts < 200 cells/mm3:

- Prophylaxis for PCP.

PER AMENDMENT 9/19/96:

- After the first 16 weeks of combined IFN alpha-2b and ddI treatment subjects may at
the discretion of the investigator receive any FDA approved antiretroviral drug
regimen in addition to or in place of ddI.

Patients must have:

- Positive antibody to HIV.

- Biopsy-proven Kaposi's sarcoma (at least 5 measurable lesions, with at least 1
measurable cutaneous lesion) involving the skin, lymph nodes, oral cavity, or
asymptomatic lesions of the GI tract not requiring systemic chemotherapy. Lung
involvement with Kaposi's sarcoma excludes.

- Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Concurrent opportunistic infection or B symptoms including unexplained fever, night
sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.

- Visceral (non-nodal) Kaposi's sarcoma requiring cytotoxic chemotherapy.

- Severe (> 2+) tumor-associated edema.

- Concurrent neoplasia other than basal cell carcinoma, or anogenital intraepithelial
neoplasia.

- Current clinical evidence of peripheral neuropathy (= or > grade 1), pancreatitis,
intractable diarrhea, or active seizure disorder not well controlled by anti-seizure
medications.

- Significant symptomatic cardiac disease.

- Medical contraindication.

Concurrent Medication:

Excluded:

- Other investigational, antiviral, immunomodulating, or antitumor agents.

- Drugs associated with peripheral neuropathy (other than ddI).

PER AMENDMENT 9/19/96:

- Other antiretroviral agents may not be taken during the first 16 weeks of combined
IFN alpha-2b and ddI treatment.

Concurrent Treatment:

Excluded:

- Radiation therapy.

Patients with the following prior conditions are excluded:

- Opportunistic infection or B symptoms including unexplained fever, night sweats,
weight loss > 10 percent, and diarrhea lasting more than 2 weeks.

- Prior grade 3 or 4 toxicity attributed to ddI therapy.

- Prior history of peripheral neuropathy (= or > grade 1), pancreatitis, intractable
diarrhea, or active seizure disorder not well controlled by anti-seizure medications.

- History of myocardial infarction or ventricular arrhythmias.

Prior Medication:

Excluded:

- Prior IFN-alpha.

- Corticosteroids, biological response modifiers, cytotoxic chemotherapy, or known
neurotoxic drugs (other than ddI or ddC) within 30 days prior to study entry.

- Therapy with antiretroviral drugs (other than ddI) within 7 days prior to study
entry.

Prior Treatment:

Excluded:

- Radiation therapy within 30 days prior to study entry.

Risk Behavior:

- Alcohol consumption is strongly discouraged.

- Patients considered to be noncompliant should be excluded.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Principal Investigator

Krown SE

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 206

NCT ID:

NCT00001114

Start Date:

Completion Date:

March 2000

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Sarcoma, Kaposi
  • Didanosine
  • Drug Interactions
  • Acquired Immunodeficiency Syndrome
  • Interferon-alpha
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

Stanford CRSPalo Alto, California  94305
University of Colorado Hospital CRSAurora, Colorado  80262
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Bmc Actg CrsBoston, Massachusetts  02118
St. Louis ConnectCare, Infectious Diseases ClinicSt Louis, Missouri  63112
Washington U CRSSt. Louis, Missouri  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Hosp. of the Univ. of Pennsylvania CRSPhiladelphia, Pennsylvania  19104