Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon Alfa in Treating Patients With Recurrent Ovarian Cancer

NCT00002734 | Completed Phase 1

• 4 other identifiers: NCI-2012-02240UAB-9502NCI-B95-0003CDR0000064633
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody, paclitaxel, and interferon alfa in treating patients who have ovarian cancer. Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon may interfere with the growth of cancer cells. Combining monoclonal antibody, chemotherapy, and interferon alfa may kill more tumor cells.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive interferon alfa subcutaneously on days 1, 3, 5, and 7; paclitaxel intraperitoneally (IP) on day 4 or topotecan IP on day 6; and 177Lu-CC49 IP on day 6. Treatment continues every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel and decreasing doses of 177Lu-CC49 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 5 patients experience dose limiting toxicity. Once the MTD of paclitaxel is determined, the dose of 177Lu-CC49 is escalated. Once the MTD of 177Lu-CC49 is determined, 90Y-CC49 is substituted. The MTD of 90Y-CC49 is then determined when administered with paclitaxel. Topotecan is then substituted for paclitaxel (administered with the MTD of 177Lu-CC49 and interferon alfa only) and escalated until the MTD is determined.

Biological: recombinant interferon alfa; Drug: chemotherapy; Drug: paclitaxel; Drug: topotecan hydrochloride; Radiation: lutetium Lu 177 monoclonal antibody CC49; Radiation: yttrium Y 90 monoclonal antibody CC49

Interventions

recombinant interferon alfa BIOLOGICAL

Arm I

chemotherapy DRUG

Arm I

paclitaxel DRUG

Arm I

topotecan hydrochloride DRUG

Arm I

lutetium Lu 177 monoclonal antibody CC49 RADIATION

Arm I

yttrium Y 90 monoclonal antibody CC49 RADIATION

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the ovary or papillary serous carcinoma of extraovarian origin * Recurrent or persistent following standard surgery and 1 or 2 chemotherapy regimens (with or without paclitaxel), i.e.: persistent disease or progression after chemotherapy with nodules less than the equivalent of 5 x 5 x 5 cm Recurrent carcinoma (after primary or secondary chemotherapy) detected clinically either by exam or rising CA 125 and with radiographic evidence of disease no greater than the equivalent of 5 x 5 x 5 cm nodules * Residual disease less than 5 x 5 x 5 cm following reassessment laparotomy * Microscopic residual disease on reassessment laparotomy after chemotherapy * Tumor TAG-72 positive by immunoperoxidase staining of original or current tumor blocks * At least 85% free flow of fluid in peritoneal cavity demonstrated by technetium-99m scan or other imaging within 2 weeks prior to treatment * No evidence of disease outside the peritoneal cavity other than retroperitoneal lymphadenopathy * No massive ascites PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-2 * WBC at least 3,500/mm3 * Platelet count at least 125,000/mm3 * Hemoglobin greater than 9 g/dL * No nucleated RBC or significant teardrop RBC morphology * Bilirubin less than 1.5 mg/dL * AST/ALT less than 4 times normal * Creatinine less than 2.0 mg/dL * HIV negative * Hepatitis B surface antigen negative * No hypersensitivity to paclitaxel, polyoxethylated castor oil, or topotecan * No other malignancy in past 5 years except basal cell skin carcinoma * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior biologic therapy and recovered * No prior monoclonal antibody therapy * No concurrent immunotherapy * No prior bone marrow or stem cell transplantation * At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered * No concurrent chemotherapy * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to the abdominal cavity * No concurrent radiotherapy * At least 3 weeks since prior major surgery and recovered * No prior intraperitoneal therapy

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Meredith R, Alvarez R, Khazaeli MB, et al.: Intraperitoneal radioimmunotherapy for refractory epithelial ovarian cancer with Lu-CC49. Minerva Biotechnologica 10: 100-107, 1998.

  RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Interferon-alpha; Drug Therapy; Paclitaxel; Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Ruby F. Meredith, MD, PhD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 24, 2004
• Study Start: March 1, 1996
• Primary Completion: April 1, 2001
• Last Updated: February 5, 2013

Record last verified: 2001-02

Locations

US (1)