NCT00020449

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill the tumor cells. Combining chemotherapy with interleukin-12 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with interleukin-12 in treating patients who have AIDS-related Kaposi's sarcoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

June 19, 2013

Status Verified

March 1, 2004

First QC Date

July 11, 2001

Last Update Submit

June 18, 2013

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcomarecurrent Kaposi sarcoma

Interventions

recombinant interleukin-12BIOLOGICAL
paclitaxelDRUG
pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed Kaposi's sarcoma (KS) * HIV positive * Evaluable disease involving the skin and/or viscera * At least 5 lesions not previously treated with local therapy if restricted to the skin * Pulmonary lesions evaluable by CT scan * Gastrointestinal lesions evaluable by visualization or fiberoptic instrumentation * Presence of at least one of the following indications for cytotoxic chemotherapy: * Pulmonary involvement * Visceral involvement * Pain * Edema * Ulcerating lesions * Decreased range of joint motion due to KS * Multiple lesions not amenable to local therapy * Lymphedema that impairs mobility or range of motion * Significant psychological impact leading to social withdrawal * Progressive disease within the past 3 weeks while receiving a stable regimen of highly active antiretroviral therapy for at least 4 weeks unless there is a need for urgent chemotherapy * Prior participation on this study allowed, provided patient was removed from study due to non-pancreatic hyperamylasemia and the following are true: * No dose-limiting toxicity by clinical and laboratory assessment * Pancreatic amylase portion normal by fractionated amylase * Lipase normal * No symptoms referable to the pancreas PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 30-100% Life expectancy: * More than 2 months Hematopoietic: * Hemoglobin at least 9.0 g/dL * Absolute neutrophil count at least 750/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin no greater than 3.8 mg/dL with direct fraction no greater than 0.3 mg/dL and indirect fraction no greater than 3.5 mg/dL if due to protease inhibitor therapy * PT or aPTT no greater than 120% of control unless due to lupus-type anticoagulant * AST no greater than 2.5 times upper limit of normal * No prior hepatic cirrhosis * No hepatic dysfunction Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min Cardiovascular: * No congestive heart failure * Ejection fraction at least 40% by MUGA or echocardiogram Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 2 months after study participation * No clinically significant autoimmune disease * No active, gross gastrointestinal bleeding or uncontrolled peptic ulcer disease * No prior inflammatory bowel disease * No other prior or concurrent malignancy except squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or malignancy in complete remission for at least 1 year from the time a response was first documented * No severe or life-threatening infection within the past 2 weeks * No abnormality that would be scored as grade 3 toxicity except lymphopenia or direct manifestations of KS * No known hypersensitivity to interleukin-12 (IL-12) or other compounds known to cross-react with IL-12 * No other medical condition that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 2 weeks since prior cytokines or colony-stimulating factors other than epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) * No prior combination interleukin-12 and doxorubicin HCl liposome except for patients previously treated on this protocol who are being enrolled for paclitaxel salvage therapy * No concurrent immunomodulatory agents * No concurrent cytokines except epoetin alfa or G-CSF Chemotherapy: * See Disease Characteristics * See Biologic therapy * At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) * More 6 months since prior suramin * No other concurrent cytotoxic chemotherapy Endocrine therapy: * More than 2 months since prior systemic glucocorticoid steroids at doses sufficient to affect immune response (e.g., more than 20 mg of prednisone for more than 1 week) * Concurrent replacement glucocorticoid therapy allowed * No other concurrent systemic glucocorticoid therapy Radiotherapy: * Not specified Surgery: * Not specified Other: * Concurrent antiretroviral therapy required * No other concurrent anti-KS therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (2)

  • Little RF, Aleman K, Kumar P, Wyvill KM, Pluda JM, Read-Connole E, Wang V, Pittaluga S, Catanzaro AT, Steinberg SM, Yarchoan R. Phase 2 study of pegylated liposomal doxorubicin in combination with interleukin-12 for AIDS-related Kaposi sarcoma. Blood. 2007 Dec 15;110(13):4165-71. doi: 10.1182/blood-2007-06-097568. Epub 2007 Sep 10.

    PMID: 17846226RESULT

  • Little RF, Aleman K, Merced K, et al.: Preliminary results of combination liposomal doxorubicin and interleukin-12 followed by chronic IL-12 maintenance therapy in advanced AIDS-related Kaposi's sarcoma. [Abstract] 10th Conference on Retroviruses and Opportunistic Infections, February 10-14, 2003, Boston, Massachusetts A-816, 2003.

    RESULT

MeSH Terms

Conditions

SarcomaAIDS-related Kaposi sarcomaSarcoma, Kaposi

Interventions

Interleukin-12 Subunit p35Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Interleukin-12InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Pallavi P. Kumar, MD

    NCI - HIV and AIDS Malignancy Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

January 1, 2001

Study Completion

May 1, 2004

Last Updated

June 19, 2013

Record last verified: 2004-03

Locations

US(1)