Phase I Bridging Trial of TG4010 as Antigen-Specific Immunotherapy in Patients With MUC-1 Positive Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase I Bridging Trial of TG4010 as Antigen-Specific Immunotherapy in Patients With MUC-1 Positive Advanced Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert A. Figlin, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

TRANSGENE-TG4010.01

NCT ID:

NCT00004881

Start Date:

April 2000

Completion Date:

May 2004

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781