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Phase I/II Study of Combination Chemotherapy (Adriamycin, Bleomycin, +/- Vincristine) and Dideoxyinosine (ddI) or Dideoxycytidine (ddC) in the Treatment of AIDS-Related Kaposi's Sarcoma


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

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Trial Information

Phase I/II Study of Combination Chemotherapy (Adriamycin, Bleomycin, +/- Vincristine) and Dideoxyinosine (ddI) or Dideoxycytidine (ddC) in the Treatment of AIDS-Related Kaposi's Sarcoma


AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic
agents to reduce the tumor burden, and they also require treatment with other possibly
effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of
opportunistic infections.

In Phase I, eligible patients with advanced Kaposi's sarcoma are randomly assigned to either
ddI or ddC in combination with DBV chemotherapy. On the average, patients receive 12-44
weeks of combined chemotherapy and antiretroviral therapy. If vincristine is deleted from
Phase I because of excess neurotoxicity, it will not be administered as part of the
combination chemotherapy if that treatment is continued in the Phase II study. The Phase II
trial proceeds when at least six cycles (12 weeks) of DBV have been completed by six
patients enrolled in Phase I, and an overall evaluation of tolerance to each combination
treatment plan has been completed. Study medication is administered as in Phase I, with the
possible deletion of vincristine. All patients who complete DBV chemotherapy with complete
or partial response or stable disease will continue to receive the originally assigned
investigational antiretroviral drug (ddC or ddI) for an additional 24 weeks.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Required:

- Prophylaxis for Pneumocystis carinii pneumonia for all patients with CD4 cell counts
< 200 cells/mm3.

Allowed:

- Chemoprophylaxis for candidiasis, MAC, and herpes simplex.

- Up to 14-day courses of metronidazole.

- Recombinant erythropoietin.

- Granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony
stimulating factor (G-CSF) for patients with ANC < 1000 cells/mm3.

- Isoniazid for treatment of tuberculosis, with permission of the protocol chair, when
given in conjunction with pyridoxine.

Patients must have:

- HIV infection.

- Kaposi's sarcoma.

For patients < 18 years of age:

- consent of parent or guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Opportunistic infection requiring treatment with myelosuppressive antibiotics (unless
on G-CSF or GM-CSF).

- Other active malignancies except basal cell carcinoma of the skin or in situ cervical
carcinoma.

- Prior history or current clinical evidence of peripheral neuropathy (= or > grade 1),
pancreatitis, intractable diarrhea, or active seizure disorder not controlled by
antiseizure medication.

- Significant pulmonary insufficiency (exertional dyspnea with minimal exertion, except
that due to pulmonary Kaposi's sarcoma) or cardiac insufficiency (New York Heart
Association status > 2).

- Neuropsychiatric history or altered mental status that would prevent informed consent
or that would not permit compliance with this protocol.

Concurrent Medication:

Excluded:

- Myelosuppressive antibiotics (unless on G-CSF or GM-CSF).

- Investigational agents other than drugs available on treatment IND and used for FDA
sanctioned indications, or other antiviral, immunomodulating or antitumor drugs.

- Drugs associated with peripheral neuropathy (other than ddI, ddC, or vincristine),
including hydralazine, disulfiram, nitrofurantoin, cisplatin, diethyldithiocarbamate,
gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide,
sodium cyanate, and thalidomide.

Patients with the following prior conditions or symptoms are excluded:

- Neuropsychiatric history or altered mental status that would prevent informed consent
or that would not permit compliance with this protocol.

Prior Medication:

Excluded:

- Systemic treatment with doxorubicin, bleomycin, or vincristine.

- Antitumor (Kaposi's sarcoma) drugs within 7 days of study entry.

- Any investigational drug (other than drugs available on treatment IND and used for
FDA sanctioned indications) within 14 days of study entry.

- Neurotoxic drugs (other than ddI or ddC) within 30 days of study entry.

- Intralesional injections to a Kaposi's sarcoma marker lesion within 30 days of study
entry.

Prior Treatment:

Excluded:

- Irradiation of a Kaposi's sarcoma marker lesion within 30 days of study entry.

Alcohol consumption is strongly discouraged.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mitsuyasu RT

Investigator Role:

Study Chair

Authority:

Unspecified

Study ID:

ACTG 163

NCT ID:

NCT00000954

Start Date:

Completion Date:

September 1996

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Vincristine
  • Sarcoma, Kaposi
  • Zalcitabine
  • Didanosine
  • Doxorubicin
  • Drug Evaluation
  • Drug Interactions
  • Drug Therapy, Combination
  • Combined Modality Therapy
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents
  • Antineoplastic Agents, Combined
  • Antiviral Agents
  • Bleomycin
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

UCLA CARE Center CRSLos Angeles, California  90095
USC CRSLos Angeles, California  90033
Ucsf Aids CrsSan Francisco, California  
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
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Bmc Actg CrsBoston, Massachusetts  02118
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
Unc Aids CrsChapel Hill, North Carolina  27599
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210