Advertisement

Topics

The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma

2014-08-27 03:59:47 | BioPortfolio

Summary

Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's sarcoma associated with HIV infection.

Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression and markers of immune function.

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.

Description

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Conditions

Sarcoma, Kaposi

Intervention

Interferon alfa-2b, Didanosine

Location

Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco
California
United States
94115

Status

Completed

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:47-0400

Clinical Trials [1187 Associated Clinical Trials listed on BioPortfolio]

A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma

To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha ...

A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma

To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha ...

The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy...

Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vacci...

A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma

To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma ...

PubMed Articles [789 Associated PubMed Articles listed on BioPortfolio]

Changes in in vivo confocal microscopic findings of ocular surface squamous neoplasia during treatment with topical interferon alfa-2b.

To evaluate in vivo confocal microscopy (IVCM) findings of ocular surface squamous neoplasia (OSSN) during treatment with topical interferon alfa-2b (IFN alfa-2b).

Disseminated Kaposi Sarcoma with Epithelioid Morphology in an HIV/AIDS Patient; A Previously Unreported Variant.

Kaposi sarcoma is an oligoclonal HHV8-driven vascular proliferation that was first described in 1872 as an "idiopathic multiple pigmented sarcoma of the skin" by a Viennese dermatologist Dr. Moriz Kap...

No association between IFNL3 (IL28B) genotype and response to peginterferon alfa-2a in HBeAg-positive or -negative chronic hepatitis B.

It has yet to be firmly established whether host IFNL3 (IL28B) genotype influences interferon responsiveness in patients with chronic hepatitis B. We investigated associations between single-nucleotid...

Suppression of HBsAg production by combination therapy with nucleotide analogues and interferon in children with genotype C Hepatitis B virus infection.

Sustained suppression of HBsAg production after interferon treatment was not reported for children with chronic hepatitis B and with genotype C infection that is prevalent in Asia. Among children with...

El sarcoma de Kaposi es un tumor linfoangioproliferativo descripto por primera vez en el año 1872 por Moritz Kaposi. Hay cuatro variantes clínicas, la forma clásica, la endémica, la iatrogénica a...

Medical and Biotech [MESH] Definitions

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. Didanosine is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA by binding to reverse transcriptase; ddI is then metabolized to dideoxyadenosine triphosphate, its putative active metabolite.

More From BioPortfolio on "The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial