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Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoma, Kaposi; HIV Infections

Intervention: Doxorubicin hydrochloride (liposomal) (Drug); Filgrastim (Drug); Bleomycin sulfate (Drug); Vincristine sulfate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Mitsuyasu R, Study Chair
Krown S, Study Chair
Von Roenn JH, Study Chair

Summary

To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.

Clinical Details

Official title: Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma

Study design: Primary Purpose: Treatment

Detailed description: Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine. Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia. AS PER AMENDMENT 11/7/96: Based on interim review data, it is recommended that subjects receiving DOX-SL plus vincristine/bleomycin have vincristine/bleomycin discontinued and receive DOX-SL alone unless, in the opinion of the treating physician, they are benefitting from the DOX-SL plus vincristine/bleomycin regimen.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria Concurrent Medication: Allowed:

- G-CSF.

- Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).

- PCP prophylaxis (required if CD4 count < 200 cells/mm3).

- Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and

herpes simplex.

- Up to 14 days of metronidazole.

- Recombinant erythropoietin.

Patients must have:

- Documented HIV infection.

- Advanced stage Kaposi's sarcoma.

- No active acute opportunistic infection.

Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:

- Significant pulmonary insufficiency (unless due to pulmonary KS).

- Significant cardiac insufficiency.

- Other active malignancies except for basal or squamous cell carcinoma of the skin or

in situ cervical cancer.

- Grade 2 or worse peripheral neuropathy.

- Altered mental status that prevents informed consent.

- Active Mycobacterium tuberculosis.

- Hypersensitivity or allergic reaction to any study drugs or E. coli-derived

medications such as filgrastim (G-CSF). Concurrent Medication: Excluded:

- GM-CSF.

- Drugs associated with peripheral neuropathy (other than approved antiretrovirals and

vincristine).

- Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and

pyridoxine is allowed as treatment for a positive PPD, with permission of study chair). Concurrent Treatment: Excluded:

- Radiation therapy to study marker lesions.

Patients with the following prior condition are excluded:

- Neuropsychiatric history.

Prior Medication: Excluded:

- Any anti-KS therapy within 21 days prior to study entry.

- Prior systemic therapy with any anthracycline (including liposomal anthracyclines),

vincristine, or bleomycin.

- Any investigational drug (other than those available through Treatment IND and used

for FDA-sanctioned purposes) within 14 days prior to study entry. PER AMENDMENT 11/29/95:

- No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma.

Locations and Contacts

Alabama Therapeutics CRS, Birmingham, Alabama 35294, United States

UCLA CARE Center CRS, Los Angeles, California 90095, United States

USC CRS, Los Angeles, California 90033, United States

Ucsf Aids Crs, San Francisco, California, United States

University of Colorado Hospital CRS, Aurora, Colorado 80262, United States

Univ. of Miami AIDS CRS, Miami, Florida 33136, United States

Queens Med. Ctr., Honolulu, Hawaii 96813, United States

Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii 96816, United States

Northwestern University CRS, Chicago, Illinois 60611, United States

Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois 60612, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana 46202, United States

Beth Israel Deaconess - East Campus A0102 CRS, Boston, Massachusetts 02215, United States

Bmc Actg Crs, Boston, Massachusetts 02118, United States

Massachusetts General Hospital ACTG CRS, Boston, Massachusetts, United States

Washington U CRS, St. Louis, Missouri 63110, United States

SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York 14215, United States

Memorial Sloan-Kettering Cancer Ctr., New York, New York 10021, United States

Additional Information

Click here for more information about Doxorubicin hydrochloride (liposomal)

Related publications:

Mitsuyasu R, et al. Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS Clinical Trial Group (ACTG) protocol 286 (meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1997;16:A191


Last updated: April 13, 2012

Page last updated: August 23, 2015

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