Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

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

Anti-Infective Agents

Androgens

Hormones

Leuprolide

Androgen Antagonists

Bicalutamide

Squalamine

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Protective Agents

Angiogenesis Inhibitors

Growth Inhibitors

bicalutamide

leuprolide acetate

squalamine lactate

adjuvant therapy

antiandrogen therapy

antiangiogenesis therapy

conventional surgery

neoadjuvant therapy

releasing hormone agonist therapy

Mitchell Sokoloff, MD, FACS

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving hormone therapy together with squalamine lactate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together with squalamine lactate works compared to hormone therapy alone in treating patients who are undergoing a radical prostatectomy for locally advanced prostate cancer.

OBJECTIVES:

* Compare the effect of neoadjuvant androgen-ablation therapy with vs without squalamine lactate on induced tumor regression and grade migration in patients with locally advanced high-risk adenocarcinoma of the prostate undergoing a radical prostatectomy.
* Compare the duration of clinical disease-free survival of patients treated with these regimens.
* Determine the applicability of prostate-specific antigen (PSA) serology as an endpoint determinant in patients treated with these regimens.
* Compare the feasibility and potential safety effects on wound healing and recovery in patients treated with these regimens before and after a radical prostatectomy.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive leuprolide intramuscularly once a month for 3 months and oral bicalutamide once a day for 2 weeks.
* Arm II: Patients receive leuprolide and bicalutamide as in arm I plus squalamine lactate IV over 4 hours once weekly for 6 weeks.

Seven weeks after beginning treatment, patients in both arms undergo standard radical prostatectomy. Patients then continue to receive leuprolide and bicalutamide with or without squalamine lactate for up to 6 additional weeks.

After completion of study treatment, patients are followed periodically for at least 3 years.

PROJECTED ACCRUAL: A total of 132 patients (66 per treatment arm) will be accrued for this study.

Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer

An Open Label Randomized Phase 2 Study To Evaluate The Activity, Tolerability, And Toxicity Of Combined Neoadjuvant Anti-angiogenesis and Androgen Ablation Therapy in Men Undergoing Radical Prostatectomy

National Cancer Institute (NCI)

OHSU Knight Cancer Institute

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Sarcoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Brenner Tumor

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Germ Cells Tumors

Ovarian Germ Cell Tumor

Ovarian Low Malignant Potential Tumor

Carboplatin

carboplatin

Linnea Chap, MD

RATIONALE: Squalamine lactate may stop or slow the growth of ovarian cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining squalamine lactate with carboplatin may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining squalamine lactate and carboplatin in treating patients who have recurrent or refractory stage III or stage IV ovarian cancer.

OBJECTIVES: I. Determine the response rate and time to progression in patients with recurrent or refractory stage III or IV ovarian cancer treated with squalamine lactate and carboplatin. II. Determine the safety profile of this regimen in these patients.

OUTLINE: Patients receive carboplatin IV over 15-30 minutes on day 1 and squalamine lactate IV continuously on days 1-5. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at approximately 1 month.

PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.

Squalamine Lactate Plus Carboplatin in Treating Patients With Recurrent or Refractory Stage III or Stage IV Ovarian Cancer

A Phase IIA Trial of Continuous Five Day Infusions of MSI-1256F (Squalamine Lactate) Plus Carboplatin for Therapy of Refractory and Resistant Stage III and IV Ovarian Cancer

Jonsson Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer	NCT00244920	Prostate Cancer	bicalutamide leuprolide acet... squalamine lact... adjuvant therap... antiandrogen th... antiangiogenesi... conventional su... neoadjuvant the... releasing hormo...	18 Years -	OHSU Knight Cancer Institute
Squalamine Lactate Plus Carboplatin in Treating Patients With Recurrent or Refractory Stage III or Stage IV Ovarian Cancer	NCT00021385	Ovarian Cancer	carboplatin squalamine lact...	18 Years -	National Cancer Institute (NCI)

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