Clinical trial · Interventional
Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma
A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With CNS Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): MyVax did not meet its primary endpoints
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a person's cancer proteins may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may make a stronger immune response and kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy together with GM-CSF works in treating patients with CNS lymphoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Biological | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- methotrexate IV once every 2 weeks
- interventionNames
- Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
- Biological: sargramostim
- Drug: methotrexate
- Drug: thiotepa
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF
- measure
- Safety and tolerability
Secondary outcomes (4)
- measure
- Progression-free survival (PFS)
- measure
- Time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or CSF cytologically confirmed CNS lymphoma with any of the following clinical histories: * Primary CNS lymphoma at initial diagnosis * Primary CNS lymphoma at relapse * Systemic lymphoma with CNS disease at initial diagnosis or at relapse * Adequate fresh tissue or cell pellet available for analysis by Genitope Corporation to determine adequacy for idiotype (Id) manufacturing * Tumor must express both functional light and heavy chain genes * No tumors known or found to be surface immunoglobulin negative * Not in leukemic phase (i.e., \> 5,000/mm³ circulating tumor cells) PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% * WBC ≥ 1,500/mm³ * Platelet count ≥ 75,000/mm³ * Hemoglobin ≥ 10 g/dL * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease) * Creatinine ≤ 1.5 times ULN * Able to undergo placement of an Ommaya reservoir * Able to receive induction therapy (chemotherapy with or without brain radiotherapy) with intent to induce remission * Speaks English or Spanish * No other malignancy within the past 3 years, except adequately treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ * Not pregnant or nursing * No immunosuppressive viral infections as evidenced by HIV antibody or antigen, hepatitis B antigen, or hepatitis C antibody or antigen positivity * No history of autoimmune disease that required treatment within the past 5 years, including previously treated autoimmune hemolytic anemia or immune thrombocytopenia PRIOR CONCURRENT THERAPY: * More than 30 days since prior and no concurrent participation in another therapeutic clinical trial * More than 2 weeks since prior steroids * No concurrent immunosuppressives, including corticosteroids * Transient use of optical or nasal steroid solutions is allowed * No other concurrent anticancer therapy or therapy for non-Hodgkin lymphoma
References
Publications (0)
Data not yet available