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Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma


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

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Trial Information

Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma

Inclusion Criteria


Inclusion Criteria

Patients must have the following:

- Biopsy proven Kaposi's sarcoma in advanced stages.

- Positive HIV antibody, HIV culture or antigen capture or T4 cells < 500 in a patient
with AIDS risk factor.

- Informed consent and availability for follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Uncontrolled opportunistic infection.

- Any medical, surgical or psychiatric condition which would constitute a
contraindication to the use of mitoxantrone.

Concurrent Medication:

Excluded:

- Zidovudine (AZT).

Patients with the following are excluded:

- Uncontrolled opportunistic infection.

- Unable to give informed consent.

- Any medical, surgical or psychiatric condition which would constitute a
contraindication to the use of mitoxantrone.

Prior Medication:

Excluded:

- More than one form of chemotherapy regimen.

- Doxorubicin therapy > 300 mg/m2.

Prior Treatment:

Excluded:

- Previous therapy consisting of more than one modality of therapy (e.g., chemotherapy
plus radiotherapy or more than one form of chemotherapy regimen.)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

055B

NCT ID:

NCT00002259

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Mitoxantrone
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025