Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Androgens

Hormones

Leuprolide

Goserelin

Bicalutamide

Flutamide

Semaxinib

Antineoplastic Agents, Hormonal

Androgen Antagonists

Hormone Antagonists

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Subjects receive 5 months of hormone suppression therapy consisting of 1 month of Bicalutamide or Flutamide followed by 4 months of leuprolide or goserlin injections. After completion of at least 12 weeks of hormone therapy, subjects will receive 7 1/2 weeks of radiation therapy. SU5416 will be given by IV infusion starting 4 weeks before beginning radiation treatment and continuing until 4 weeks after completion of radiation. Multiple doses of SU5416 will be studied.

bicalutamide

flutamide

goserelin acetate

leuprolide acetate

SU5416

radiation therapy

Walter M. Stadler, MD, FACP

RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, bicalutamide, leuprolide, or goserelin may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining SU5416, hormone therapy, and radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of SU5416 plus hormone therapy and radiation therapy in treating patients who have prostate cancer.

OBJECTIVES: I. Determine the safety of SU5416 in combination with standard androgen ablation and radiotherapy in patients with intermediate or advanced-stage prostate cancer.

OUTLINE: This is a multicenter, dose-escalation study of SU5416. Patients receive oral bicalutamide once daily or oral flutamide three times daily for at least 1 month followed by leuprolide or goserelin subcutaneously once monthly for four months. Beginning after the fourth administration of leuprolide or goserelin, patients undergo radiotherapy 5 days a week for 7-8 weeks. Beginning one month before radiotherapy and continuing until 1 month after radiotherapy, patients receive SU5416 IV over 60 minutes on days 1 and 4. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity. Cohorts of 3-12 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 3 of 12 patients experience dose-limiting toxicity. Patients are followed every 4-6 weeks for 4 months and then every 8-12 weeks for 8 months.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.

SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer

National Cancer Institute (NCI)

University of Chicago

Infections

Symptoms and General Pathology

Immune System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Sarcoma

Skin Neoplasms

Sarcoma, Kaposi

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.

Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.

Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

SUGEN

Syndrome

Immunologic Deficiency Syndromes

Amino Acids

Tyrosine

The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).

Patients are given SU5416 via twice-weekly intravenous infusions in 4-week treatment cycles. Any patient who has not experienced unacceptable toxicity and who is deemed to be responding to the study drug (no evidence of disease progression) is permitted to continue receiving SU5416 in 4-week treatment cycles (up to a maximum of 1 year of therapy) until that patient experiences either unacceptable toxicity or tumor progression, as defined in the protocol.

SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment

A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer	NCT00026377	Prostate Cancer	bicalutamide flutamide goserelin aceta... leuprolide acet... SU5416 radiation thera...	-	University of Chicago
Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma	NCT00002226	Sarcoma, Kaposi HIV Infections	SU5416	18 Years -	NIH AIDS Clinical Trials Information Service
SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment	NCT00005931	Sarcoma, Kaposi HIV Infections	SU5416	18 Years -	NIH AIDS Clinical Trials Information Service
Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma	NCT00002226	Sarcoma, Kaposi HIV Infections	SU5416	18 Years -	NIH AIDS Clinical Trials Information Service

Spots Global Cancer Trial Database for su5416

Every month we try and update this database with for su5416 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for su5416

Every month we try and update this database with for su5416 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for su5416 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.