Clinical trial · Interventional
Derivation of Tumor Specific Hybridomas
Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
NCT01702792CI-TRIAL-00032341terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator is leaving Dartmouth
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor Vaccine
- description
- 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.
- interventionNames
- Biological: Tumor Vaccine
Primary outcomes (1)
- measure
- number of hybridoma clones that produce anti-glioma antibodies
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.