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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Advanced Cancer  Vaccine Therapy in Treating Patients With Advanced Cancer
Vaccine Therapy in Treating Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertFiglin, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000067544; UCLA-9909055,NCI-G00-1677,TRANSGENE-TG4010.01
Study Start Date: April 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004881
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
2. BMS-214662 in Treating Patients With Solid Tumors
3. E7389 in Treating Patients With Advanced Solid Tumors
4. Interleukin-2 Plus Activated White Blood Cells in Treating Patients With Cancer That Has Not Responded to Chemotherapy or Radiation Therapy
5. Methylphenidate in Treating Patients With Melanoma
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy in Treating Patients With Advanced Cancer
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