Brain and Central Nervous System Tumors Clinical Trial
Official title:
Randomized Phase II Trial of Intralesional Lymphokine Activated Killer Cells or Polifeprosan 20 With Carmustine Implant (Gliadel® Wafer) as Consolidation Therapy After Primary Treatment of Newly Diagnosed Resectable Glioblastoma
Verified date | May 2019 |
Source | Caladrius Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the
immune system in different ways and stop tumor cells from growing. Drugs used in
chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. It is not yet known
whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating
patients with glioblastoma multiforme.
PURPOSE: This randomized phase II trial is studying the side effects and how well
lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with
newly diagnosed glioblastoma multiforme that can be removed by surgery.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed primary malignant glioblastoma multiforme (GBM) (i.e., grade IV anaplastic astrocytoma) - Must have undergone standard primary therapy (e.g., surgery, radiotherapy, and temozolomide) within the past 90 days - Additional anticancer therapy as part of first-line therapy, including a radiosurgical procedure (e.g., stereotactic or gamma knife radiosurgery) allowed - Must be an operable candidate and willing to undergo craniotomy PATIENT CHARACTERISTICS: - Karnofsky performance status 70-100% - Life expectancy = 2 months - Hemoglobin > 10.0 g/dL - AGC > 1,500/mm³ - Platelet count > 100,000/mm³ - Serum total bilirubin < 1.5 times upper limit of normal (ULN) - ALT and AST < 2.5 times ULN - Serum creatinine < 1.5 times ULN - Negative pregnancy test - Resides in the United States of America - Venous access available for leukapheresis procedure to obtain peripheral blood mononuclear cells - No diagnosis of any other invasive cancer within the past 5 years, except in situ carcinoma or basal cell carcinoma or localized squamous cell carcinoma of the skin - Patients with prior diagnosis of minimal microscopic cancer (e.g., colonic polyp or stage I prostate cancer with Gleason score < 6) may be eligible, as determined by the principal investigator - No concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study - No known hypersensitivity or allergy to either carmustine or aldesleukin PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 3 weeks since prior anticancer therapy and recovered - No polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of prior surgery for GBM - No prior treatment for progressive disease - No other concurrent anticancer therapy (e.g., continuation of hormonal therapy for breast or prostate cancer that was diagnosed > 5 years ago) |
Country | Name | City | State |
---|---|---|---|
United States | Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian | Newport Beach | California |
Lead Sponsor | Collaborator |
---|---|
Caladrius Biosciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | 5 years or death, whichever came first. | ||
Secondary | Rate of significant surgical wound infection (grade 3 or 4) | 4 weeks from date of study treatment. | ||
Secondary | Rate of grade 3 or 4 non-infectious wound complications | 4 weeks from date of study treatment. | ||
Secondary | Toxicity as assessed by NCI CTCAE version 3.0 | 4 weeks from date of study treatment. |
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