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Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma


VP-16 is an antitumor agent. Previous problems with VP-16 include the route of
administration and the toxicities. VP-16 has been given intravenously for 3 consecutive days
in a 21-day cycle for lung cancer and testicular cancer. VP-16 has also been used in
lymphoma therapy. Oral VP-16 would eliminate the need for an intravenous catheter and so a
patient could avoid the pain, inconvenience, and potential complications associated with
medications administered intravenously. The relative ease of outpatient administration and
the potentially significant antitumor activity of oral VP-16 motivates this study. The
possibility of weekly drug administration is the other focus of this study.

Four patients are entered at each dose level starting with level 1. Patients are not entered
into the next higher dose level until at least two patients at the previous dose level have
completed at least 3 weeks of therapy with grade 2 or less maximum tolerated dose-defining
toxicities. Treatment is repeated weekly for 52 weeks until either a grade 3 or 4 toxicity
occurs, or until a patient shows a complete response or progressive disease. Patients with a
complete response are continued on drug for 4 additional weeks from the time that complete
response is first documented. Patients with progressive disease are withdrawn from study.
Patients with partial response or stable disease continue until either unacceptable toxicity
occurs or a complete response or progression of disease is reached.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

AMENDED:

- 04-21-91 Zidovudine (AZT) allowed after completing 8 weeks on the study. Patients on
reduced doses of VP-16 must have tolerated at least 4 consecutive weeks at the
reduced dose before starting AZT. Zidovudine will not be provided by the NIAID
Clinical Product Research Repository.

AMENDED:

- Zidovudine (AZT) allowed after completing 12 weeks on study.

Allowed:

- Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis (PCP).

Concurrent Treatment:

Allowed:

- Local radiotherapy or laser therapy to cosmetically apparent, non-indicator lesions
provided the dose to any one lesion does not exceed 300 rads and the total surface
area of all lesions treated does not exceed 10 cm2.

Risk Behavior:

Allowed:

- All risk groups.

Patients must:

- Have AIDS-related Kaposi's sarcoma.

- Be ineligible for protocols of higher priority at study center.

- Be willing to sign an informed consent or have guardian willing to sign.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Active opportunistic infection not specifically allowed.

- Concurrent neoplasm not specifically allowed.

- Significant neurologic, cardiac, or liver disease.

Concurrent Medication:

Excluded:

- Therapy with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs for an
opportunistic infection.

Patients with the following are excluded:

- Active opportunistic infection not specifically allowed.

- Ongoing therapy, including maintenance therapy, for an opportunistic infection with
potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs.

- Concurrent neoplasm not specifically allowed.

- Significant neurologic, cardiac, or liver disease.

Prior Medication:

Excluded:

- Biologic response modifiers or corticosteroids within 14 days prior to study entry.

- Cytotoxic chemotherapy within 30 days prior to study entry.

- Ribavirin within 6 weeks prior to study entry.

- Azidothymidine (AZT), alpha-interferon, didanosine (ddI), ganciclovir (DHPG), or any
other antiretroviral drugs within 1 week prior to study entry.

Prior Treatment:

Excluded within 30 days prior to study entry:

- Radiation therapy with > 4000 rads.

- Total skin electron beam therapy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Principal Investigator

J Kahn

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 110

NCT ID:

NCT00000660

Start Date:

Completion Date:

July 1992

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Sarcoma, Kaposi
  • Drug Evaluation
  • Etoposide
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169