Neoplasms

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Sarcoma

Sarcoma, Kaposi

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Communicable Diseases

Herpesviridae Infections

Virus Diseases

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients receive oral sunitinib malate 50 mg once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

sunitinib malate

laboratory biomarker analysis

pharmacological study

Scot Remick

Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying the side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma.

PRIMARY OBJECTIVES:

I. Determine the clinical response of sunitinib malate in patients with Kaposi sarcoma (KS) in Uganda and Kenya.

II. Compare clinical response rates in endemic versus epidemic (AIDS) KS. III. Determine the safety and tolerability of sunitinib malate in patients with endemic or epidemic (AIDS) KS.

SECONDARY OBJECTIVES:

I Monitor the impact of sunitinib malate on underlying HIV-1 and Kaposi sarcoma-associated herpesvirus (KSHV) viral infection (HIV-1 plasma RNA and KSHV cell-associated DNA).

II. Evaluate morphological changes in KS lesions after treatment. III. Determine the pharmacokinetic profile of sunitinib malate in patients with KS.

IV Evaluate KSHV gene expression in endemic and epidemic KS lesions in patients in Uganda and Kenya.

OUTLINE: This is a multicenter study. Patients are stratified according to HIV-serostatus (endemic \[HIV-seronegative\] vs epidemic \[HIV-seropositive/AIDS\] kaposi sarcoma).

Patients receive oral sunitinib malate 50 mg once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative and pharmacokinetic studies. Samples are analyzed for CD4 lymphocyte counts, HIV-1 plasma RNA levels, KSHV specific antibodies, expression pattern of KSHV in vitro and in vivo, expression of latently versus lytically expressed genes in tumor tissue, and plasma concentrations of sunitinib malate and its active metabolite, SU12662.

After completion of study treatment, patients are followed every 6 weeks.

Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma

Phase II Study of Sunitinib (SU11248) in Patients With Kaposi's Sarcoma in East Africa

The true response rate will be estimated based on the number of responses using a binomial distribution. The confidence intervals for them can be estimated using same distribution. Chi-square test or Fisher's exact test will be used to examine the difference of response rate between the two cohorts and log-rank test for the difference of survival outcomes.

Will be estimated by Kaplan-Meier method.

Multivariate analysis will be performed using the Cox proportional hazards model. The effects of CD4+ lymphocyte counts, plasma HIV-1 RNA viral load and KSHV DNA level on the objective response rate will be evaluated using multivariate logistic regression.

For each treatment cohort and for all groups combined, the Wilcoxon signed rank test (the non-parametric version of paired T-test) will be used to evaluate the changes.

National Institute of Allergy and Infectious Diseases (NIAID)

National Cancer Institute (NCI)

Recurrence

Anti-Infective Agents

Valganciclovir

Antiviral Agents

Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.

valganciclovir

Susan E. Krown, MD

RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients with classic non-HIV-associated Kaposi's sarcoma.

OBJECTIVES:

Primary

* Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposi's sarcoma (KS).

Secondary

* Determine the effect of this drug on lytic and latent human herpesvirus-8 gene expression in KS lesions of these patients.
* Determine the effect of this drug on the markers of angiogenesis in KS lesions of these patients.
* Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a pilot study.

Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity.

All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.

Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma

Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma

New York Presbyterian Hospital

Weill Medical College of Cornell University

University of North Carolina, Chapel Hill

Memorial Sloan Kettering Cancer Center

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Ariela Noy

Progression of Disease

Stable Disease

Tumor Response Rate Every 4 Weeks

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Cidofovir

cidofovir

Robert Yarchoan, MD

RATIONALE: Herpesvirus is found in Kaposi's sarcoma lesions in most patients; it is therefore possible that the herpesvirus has a role in causing Kaposi's sarcoma. Cidofovir is an antiviral drug that acts against many types of herpesvirus, and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: Phase II trial to study the effectiveness of cidofovir in treating patients with Kaposi's sarcoma with or without HIV infection.

OBJECTIVES: I. Assess the antitumor activity of intravenous cidofovir in patients with Kaposi's sarcoma (KS) with and without human immunodeficiency virus (HIV) infection. II. Assess the effect of intravenous cidofovir on the load of KS-associated herpesvirus/human herpesvirus-8 in KS lesions and peripheral blood mononuclear cells by quantitative polymerase chain reaction. III. Assess the toxicity of cidofovir in KS patients with and without HIV infection. IV. Assess the effect of cidofovir on angiogenic cytokines related to the pathogenesis of KS.

OUTLINE: All patients receive intravenous cidofovir weekly for 2 weeks, then every other week for 6 months. Patients with a complete or partial response may continue treatment until disease progression intervenes.

PROJECTED ACCRUAL: Up to 25 evaluable patients will be entered over approximately 6 months if there are at least 2 responses in the first 15 patients.

Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection

PHASE II PROTOCOL WITH LABORATORY CORRELATES OF 1-[(S)-3-HYDROXY-2-(PHOSPHOMETHOXY)PROPYL]CYTOSINE DIHYDRATE(CIDOFOVIR) IN PATIENTS WITH KAPOSI'S SARCOMA (KS)

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

nicotine

James J. Goedert, MD

RATIONALE: Nicotine may stimulate the immune system to kill Kaposi's sarcoma cells.

PURPOSE: This phase II trial is studying the side effects and how well the nicotine skin patch works in treating patients with Kaposi's sarcoma.

OBJECTIVES:

* Evaluate the toxicity and efficacy of transdermal nicotine applied to lesions in patients with classic Kaposi's Sarcoma.

OUTLINE: This is a double-blind, placebo-controlled study.

Patients apply a nicotine dermal patch to a selected lesion and a placebo patch to the other lesion, replacing the same type of fresh patch every other day, during the first 2 weeks, increasing the nicotine dose in week 3 and again in week 5 for a total of 15 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

Treatment of Classical Kaposi Sarcoma With Nicotine Dermal Patch: A Phase II Trial

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks

Alona Zer, MD

A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS)

A prospective, single arm, interventional study. All patients will receive IV nivolumab 3mg/kg every two weeks and ipilimumab 1mg/kg every 6 weeks. Patients will be treated until disease progression or intolerable toxicity for a maximal period of two years, with an option to re-initiate therapy upon progression in patients with prior documented response to investigational therapy (unless treatment was held for progression of disease).

Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

A Phase 2 Study of Nivolumab Plus Ipilimumab in Previously Treated Classical Kaposi Sarcoma (CKS)

including, but not limited to proteins and/or genes involved in regulating immune responses (eg PD-L1, IDO1, KYN and MSI status).

Patients will be evaluated for treatment related adverse events (AEs) on each visit during study participation and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE v4).

Patients will be evaluated for treatment related adverse events (AEs) that caused study drug interrupption and discontinuation.

Bristol-Myers Squibb

Alona Zer

Senior Physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma	NCT00521092	AIDS-related Ka... Classic Kaposi ...	sunitinib malat... laboratory biom... pharmacological...	18 Years -	National Cancer Institute (NCI)
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma	NCT00096538	Sarcoma	valganciclovir	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma	NCT00096538	Sarcoma	valganciclovir	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma	NCT00096538	Sarcoma	valganciclovir	18 Years - 120 Years	Memorial Sloan Kettering Cancer Center
Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection	NCT00019240	Sarcoma	cidofovir	18 Years -	National Cancer Institute (NCI)
Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma	NCT00295984	Sarcoma	nicotine	18 Years - 78 Years	National Cancer Institute (NCI)
Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection	NCT00019240	Sarcoma	cidofovir	18 Years -	National Cancer Institute (NCI)
Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)	NCT03219671	Classic Kaposi ...	Nivolumab Ipilimumab	18 Years -	Rabin Medical Center
Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma	NCT00295984	Sarcoma	nicotine	18 Years - 78 Years	National Cancer Institute (NCI)
Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection	NCT00019240	Sarcoma	cidofovir	18 Years -	National Cancer Institute (NCI)
Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma	NCT00521092	AIDS-related Ka... Classic Kaposi ...	sunitinib malat... laboratory biom... pharmacological...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for classic kaposi sarcoma