Vaccine Therapy in Treating Patients With Advanced Cancer

• ClinicalTrials.gov Identifier: NCT00004881
• Recruitment Status: Completed
• First Posted: May 25, 2004
• Last Update Posted: June 26, 2013
• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: March 7, 2000
• First Posted Date: May 25, 2004
• Last Update Posted Date: June 26, 2013
• Study Start Date: April 2000
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vaccine Therapy in Treating Patients With Advanced Cancer
• Official Title: Phase I Bridging Trial of TG4010 as Antigen-Specific Immunotherapy in Patients With MUC-1 Positive Advanced Cancer

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced cancer.

Detailed Description

OBJECTIVES: I. Determine the safety, tolerance, and maximum tolerated dose of TG4010 in patients with MUC1 positive advanced cancer. II. Determine the biological and immunological effects of this regimen in this patient population.

OUTLINE: This is a dose escalation study. Patients receive TG4010 IM weekly for 4 weeks, every other week for 8 weeks, and then every 4 weeks. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of TG4010 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience treatment related grade 3 toxicity. If any patient experiences grade 4 toxicity, the prior dose level is considered the MTD.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 months.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Primary Purpose: Treatment
• Condition: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention: Biological: MVA-MUC1-IL2 vaccine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: May 2004
• Primary Completion Date: Not Provided

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed cancer not amenable to cure by any standard modality and not suitable for accepted palliative care with chemotherapy, immunotherapy, or hormonal therapy Histologically confirmed MUC1 antigen expression No uncontrolled or symptomatic CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Transaminase no greater than 3 times ULN (unless attributable to metastatic disease) Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study HIV negative No active systemic infections No other serious concurrent systemic medical disorders that would preclude study compliance No history of, or immediate household contact with, eczema, exfoliative skin disorders, pregnant women, children under 3 years of age, or other immunocompromise offering an increased risk for disseminated vaccinia infection

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosamines and mitomycin) No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent systemic corticosteroid therapy No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: No concurrent immunosuppressive drugs No other concurrent experimental protocol No other concurrent antitumor therapy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00004881
• Other Study ID Numbers: TRANSGENE-TG4010.01; UCLA-9909055-01B; CDR0000067544 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-G00-1677
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Jonsson Comprehensive Cancer Center
• Original Study Sponsor: National Cancer Institute (NCI)
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Robert A. Figlin, MD, FACP; Jonsson Comprehensive Cancer Center

• PRS Account: National Cancer Institute (NCI)
• Verification Date: February 2001