Clinical trial · Interventional
Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
NCT00004024CI-TRIAL-00009909completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and radiation therapy in treating patients who have primary or recurrent astrocytoma or oligodendroglioma.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| autologous tumor cell vaccine | Biological | — | UNRESOLVED |
| muromonab-CD3 | Biological | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| surgical procedure | Procedure | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven grade II, III, or IV astrocytoma or oligodendroglioma
* Evidence of primary or recurrent tumor by MRI
* Resectable disease
* At least 20,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0 or 1
Life expectancy:
* At least 6 months
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least lower limit of normal
* No active or recent uncontrolled bleeding
Hepatic:
* Bilirubin normal
* SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
Renal:
* Creatinine normal
Other:
* Able to be weaned off steroids
* Negative stool guaiac
* No impaired immunity
* No uncontrolled diabetes
* No active uncontrolled infections
* No other serious disease
* No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical conditions that would preclude compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No concurrent chemotherapy except for progressive disease
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* Radium implants allowed
Surgery:
* Not specified
Other
* At least 1 week since prior therapy and recoveredReferences
Publications (1)
- RESULTSloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Neurosurg Focus. 2000 Dec 15;9(6):e9. doi: 10.3171/foc.2000.9.6.10. PMID 16817692