Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

oglufanide disodium

Agustin Garcia, MD

RATIONALE: IM-862 may stop the growth of ovarian cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of IM-862 in treating patients who have recurrent ovarian cancer after treatment with chemotherapy and surgery.

OBJECTIVES: I. Determine the maximum tolerated dose of IM-862 administered intranasally in patients with recurrent ovarian cancer. II. Determine the toxicity of this regimen in this patient population. III. Obtain preliminary data regarding the efficacy of this drug in these patients. IV. Evaluate the effect of this drug in serum levels of vascular endothelial growth factor and transforming growth factor in this population.

OUTLINE: This is a dose escalation study. Patients receive IM-862 intranasally daily. Treatment continues for 6 months in the absence of unacceptable toxicity or disease progression. At the physician's discretion, further treatment may be given if the patient is still responding after 6 months of treatment. The dose of IM-862 is escalated in cohorts of 10-20 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 or 5 of 20 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 20-70 evaluable patients will be accrued for this study within 6-9 months.

IM-862 in Treating Patients With Recurrent Ovarian Cancer

Phase I Study of Escalating Doses of IM-862 in Patients With Ovarian Cancer

National Cancer Institute (NCI)

University of Southern California

Digestive System Diseases

Adenocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Oculocerebral Syndrome With Hypopigmentation

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Fluorouracil

Irinotecan

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Cola

fluorouracil

irinotecan hydrochloride

Heinz-Josef Lenz, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may stop the growth of colorectal cancer by stopping blood flow to the tumor. It is not yet known if chemotherapy is more effective with or without IM-862 in treating colorectal cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in treating patients who have metastatic colorectal cancer.

OBJECTIVES: I. Compare the efficacy of fluorouracil with or without IM-862 in terms of progression free survival in patients with previously untreated or recurrent metastatic adenocarcinoma of the colon or rectum. II. Determine the toxicity of IM-862 and fluorouracil in these patients. III. Determine the efficacy of IM-862 in combination with irinotecan in terms of progression free survival in patients who have disease progression after receiving fluorouracil. IV. Obtain preliminary data on molecular markers of response and time to progression by determining levels of genes involved in adhesion, angiogenesis, apoptosis, and drug resistance prior to and during chemotherapy. V. Determine the molecular correlates for response and time to progression through analysis of serum and urine markers of angiogenesis, such as vascular endothelial growth factor and fibroblast growth factor, in patients treated with IM-862 in combination with fluorouracil or irinotecan. VI. Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. Patients are randomized to one of two treatment arms: Arm I: Patients receive fluorouracil IV continuously on days 1-21 and IM-862 intranasally three times daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression. Patients who develop disease progression are taken off fluorouracil and IM-862, and then receive irinotecan IV over 90 minutes weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression. Arm II: Patients receive fluorouracil as in arm I and placebo intranasally three times daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression. Patients who develop disease progression are taken off fluorouracil and placebo, and then receive irinotecan and IM-862 as in arm I on days 1-42. Courses repeat every 6 weeks in the absence of disease progression. Quality of life is assessed prior to study, and then prior to every course during study. Patients are followed for a minimum of 6 months.

PROJECTED ACCRUAL: A total of 66 patients (33 per arm) will be accrued for this study within 26-27 months.

Chemotherapy Plus IM-862 in Treating Patients With Metastatic Colorectal Cancer

Phase II Randomized Placebo-Controlled Double-Blinded Study With 5-FU vs. 5-FU With IM862 With Cross-Over to CPT-11 vs. CPT-11 With IM862

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Brenner Tumor

Cystadenocarcinoma, Mucinous

Adenocarcinoma of the Appendix

Brenner Tumor of Ovary

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

carboplatin

paclitaxel

conventional surgery

Pamela Paley, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.

OBJECTIVES: I. Determine the complete pathologic response rate at second-look surgery in patients with optimally resected stage III ovarian epithelial or primary peritoneal cancer treated with adjuvant paclitaxel, carboplatin, and IM-862. II. Determine the safety profile of this regimen in this patient population. III. Determine the incidence of infectious and hematologic complications in patients treated with this regimen. IV. Determine the progression-free survival of patients with no disease or minimal disease burden after initial therapy, when treated with IM-862 consolidation therapy. V. Correlate angiogenesis markers and immunologic parameters with response in patients treated with this regimen.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of three IM-862 doses. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with IM-862 begins within 10 days of chemotherapy initiation and continues until clinical evidence of disease progression or until 3 days before second-look surgery. Arm I: Patients receive a low-dose of IM-862 and 2 placebo doses intranasally daily. Arm II: Patients receive a medium-dose of IM-862 and 2 placebo doses as in arm I. Arm III: Patients receive higher-dose IM-862 intranasally three times daily. Patients undergo second-look surgery within 4-8 weeks after completion of the last course of chemotherapy. Patients with a complete pathologic response or only microscopically detectable residual disease receive consolidation therapy with IM-862, according to their original treatment arm. Consolidation therapy begins within 3-14 days after second-look surgery and continues for 24 weeks in the absence of disease progression. Patients are followed at 6 and 12 months.

PROJECTED ACCRUAL: A total of 180 patients (60 per arm) will be accrued for this study within 1 year.

Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer

A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy

Cytran

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IM-862 in Treating Patients With Recurrent Ovarian Cancer	NCT00003773	Ovarian Cancer	oglufanide diso...	18 Years -	University of Southern California
Chemotherapy Plus IM-862 in Treating Patients With Metastatic Colorectal Cancer	NCT00006037	Colorectal Canc...	fluorouracil irinotecan hydr... oglufanide diso...	18 Years -	University of Southern California
Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer	NCT00017303	Ovarian Cancer Primary Periton...	carboplatin oglufanide diso... paclitaxel conventional su...	18 Years -	National Cancer Institute (NCI)
Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer	NCT00017303	Ovarian Cancer Primary Periton...	carboplatin oglufanide diso... paclitaxel conventional su...	18 Years -	National Cancer Institute (NCI)

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