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Phase I Trial of TGFB2-Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine for Advanced Cancer

Phase 1
18 Years
Open (Enrolling)
Carcinoma, Advanced Metastatic

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Trial Information

Phase I Trial of TGFB2-Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine for Advanced Cancer

Inclusion Criteria:

- Histologically confirmed advanced or metastatic non-curable solid tumor (if limited
to a single lesion and not a candidate for curative surgery or radiation therapy).

- Completed ≥1 conventional therapy.

- Clinically indicated surgery or procedure to collect available tumor in sufficient
quantity ("golf ball size," pleural or ascites fluid may also be collected) for
vaccine processing.

- Subjects that have completed all acceptable therapies that are the current standard
of care for their respective diseases.

- Recovered from all toxicities related to prior therapies.

- Subjects with brain metastases treated at least ≥2 months prior to enrollment,
without related clinical symptoms and must have a stable neurological exam on the
screening evaluation.

- ≥1 measurable or evaluable lesion.

- Age ≥18 years.

- ECOG performance status (PS) 0-1.

- Normal organ and marrow function:

- Absolute granulocyte count: ≥1,500/mm3

- Platelets: ≥100,000/mm3

- Total bilirubin: ≤2 mg/dL

- AST(SGOT)/ALT(SGPT): ≤2x institutional upper limit of normal

- Creatinine: <1.5 mg/dL

- Ability to understand and the willingness to sign a written informed consent

- Negative pregnancy test.

Exclusion Criteria:

- Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or
immunotherapy within 4 weeks prior to entering the study.

- Patient must not have received any other investigational agents within 30 days prior
to study entry.

- Patients with known brain metastases unless treated and stable for ≥2 months.

- Patients with mucinous adenocarcinoma.

- Short term (<30 days) concurrent systemic steroids ≤ 0.125 mg/kg prednisone per day
(maximum 10 mg/day) and bronchodilators (inhaled steroids) are permitted; other
steroid regimens and/or immunosuppressives are excluded. Patients requiring steroids
following previous CNS radiation for metastatic disease are excluded.

- Prior splenectomy.

- Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission
for ≥2 years.

- Kaposi's Sarcoma.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patients who are pregnant or nursing.

- Patients who are HIV positive.

- Patients with chronic Hepatitis B and C infection.

- Patients with a history of autoimmune diseases.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine safety following the administration of TAG vaccine in advanced solid tumor patients who have no acceptable form of standard therapy.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Minal Barve, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mary Crowley Cancer Research Centers


United States: Food and Drug Administration

Study ID:

MCMRC #08-08



Start Date:

May 2008

Completion Date:

Related Keywords:

  • Carcinoma, Advanced Metastatic
  • cancer
  • oncology
  • solid tumor
  • Carcinoma



Mary Crowley Cancer Research Centers Dallas, Texas  75201