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

NCT00684294 | Terminated Phase 1 DMC

• 1 other identifier: MCMRC #08-08
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. However, four primary factors limit the generation of effective immune mediated anticancer activity in therapeutic application:

1. 1.identifying and/or targeting cancer associated immunogen(s) in an individual patient
2. 2.insufficient or inhibited level of antigen presenting cell priming and/or presentation
3. 3.suboptimal T cell activation and proliferation
4. 4.cancer-induced inhibition of the anticancer immune response in both afferent and efferent limbs.

Conditions

Carcinoma, Advanced Metastatic

Keywords

cancer; oncology; solid tumor

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (2)

• To determine the time to progression following the administration of TAG vaccine.

  survival

• To evaluate the effect on immune stimulation.

  baseline, Month 3, and Month 6

Study Arms (2)

TAG Vaccine 1 x 10^7 cells/ injection

EXPERIMENTAL

TAG Vaccine 1 x 10\^7 cells/injection

Biological: TGFβ2 Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine

TAG Vaccine 2.5 X 10^7 cells/injection

EXPERIMENTAL

TAG Vaccine 2.5 X 10\^7 cells/injection

Biological: TGFβ2 Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine

Interventions

TGFβ2 Antisense-GMCSF Gene Modified Autologous Tumor Cell (TAG) Vaccine BIOLOGICAL

Patients with solid tumors will receive TAG Vaccine 1 x 10\^7 cells/ injection or TAG Vaccine 2.5 X 10\^7 cells/injection once a month for up to 12 doses via intradermal injection as long as sufficient material is available. Selection of cohort is dependent on the amount of tumor cell yield following harvest and processing.

TAG Vaccine 1 x 10^7 cells/ injection; TAG Vaccine 2.5 X 10^7 cells/injection

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mary Crowley Medical Research Center: lead

Study Sites (1)

Mary Crowley Cancer Research Centers

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Carcinoma; Neoplasms

Interventions

Product Labeling; Vaccines

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Product Packaging; Industry; Technology, Industry, and Agriculture; Biological Products; Complex Mixtures

Study Officials

• Minal Barve, MD

  Mary Crowley Cancer Research Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 26, 2008
• Study Start: May 27, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 28, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

US (1)