Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery

NCT00814593 | Withdrawn Phase 2

• 2 other identifiers: CDR0000630437HOAG-HCC-08-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastoma; adult gliosarcoma; adult glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  5 years or death, whichever came first.

Secondary Outcomes (3)

• Rate of significant surgical wound infection (grade 3 or 4)

  4 weeks from date of study treatment.

• Rate of grade 3 or 4 non-infectious wound complications

  4 weeks from date of study treatment.

• Toxicity as assessed by NCI CTCAE version 3.0

  4 weeks from date of study treatment.

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.

Drug: polifeprosan 20 with carmustine implant

Arm II

EXPERIMENTAL

Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy.

Biological: lymphokine-activated killer cells

Interventions

lymphokine-activated killer cells BIOLOGICAL

Instilled into the tumor bed cavity

Arm II

polifeprosan 20 with carmustine implant DRUG

Intracranial placement

Arm I

Eligibility Criteria

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

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Lisata Therapeutics, Inc.: lead

Study Sites (1)

Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Carmustine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Robert O. Dillman, MD, FACP

  Caladrius Biosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 25, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

US (1)