Derivation of Tumor Specific Hybridomas

NCT01702792 | Terminated Phase 1 DMC

• 1 other identifier: W12209
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.

Conditions

Glioblastoma

Keywords

Immunotherapy, cancer vaccine, glioblastoma, hybridoma

Outcome Measures

Primary Outcomes (1)

• number of hybridoma clones that produce anti-glioma antibodies

  The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies.

  6 months

Secondary Outcomes (4)

• Production of Antibodies

  6 months

• Toxicity of Vaccine

  6 months

• Clone Production Rate

  6 months

• Lymph Node Biopsy

  6 months

Other Outcomes (1)

• Tumor Binding Characteristics

  6 months

Study Arms (1)

Tumor Vaccine

EXPERIMENTAL

1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity.

Biological: Tumor Vaccine

Interventions

Tumor Vaccine BIOLOGICAL

Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.

Also known as: Autologous Tumor Lysate and Montanide Emulsion

Tumor Vaccine

Eligibility Criteria

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

You may qualify if:

• Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least 8x10(7) tumor cells obtained at the time of surgery
• Age \> 18 years
• KPS Score of greater than or equal to 70
• Adequate bone marrow as evidenced by:
• Absolute lymphocyte count \> 1,000/uL Platelet count \> 50,000/uL
• Adequate renal function as evidenced by serum creatinine \< 2.0
• Patients must be able to read, understand and provide informed consent to participate in the trial.
• Patients of childbearing potential must agree to use an effective form of contraception during the study and for 90 days following vaccination (an effective form of contraception is an oral contraceptive or a double barrier method)

You may not qualify if:

• A patient may not be enrolled in the trial if any of the following criteria are met:
• Patients receiving dexamethasone \> 8 mg/day during the week before vaccination.
• Patients who are pregnant or lactating
• Patients with active second malignancy.
• Any other medical conditions, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• University of Vermont: collaborator

MeSH Terms

Conditions

Glioblastoma

Interventions

Cancer Vaccines

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures

Study Officials

• Camilo Fadul, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 8, 2012
• Study Start: January 1, 2014
• Primary Completion: May 6, 2015
• Study Completion: May 6, 2015
• Last Updated: April 4, 2018

Record last verified: 2018-04