Trial | NCT00009854  Report issue

Title

Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
Phase I/II Study of Intratumoral Injection of DTI-015 Prior to Tumor Resection in Patients With Recurrent Malignant Glioma or Metastatic Neoplasm to Brain

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    carmustine ...

  • Study Participants

    None
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm.
OBJECTIVES:

Determine the extent and pattern of distribution of DNA adducts in patients with recurrent supratentorial malignant glioma or metastatic neoplasm to the brain treated with neoadjuvant intratumoral carmustine in ethanol (DTI-015) followed by tumor resection.
Determine the qualitative and quantitative toxicity of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study.

Patients receive neoadjuvant carmustine in ethanol (DTI-015) intratumorally under stereotactic guidance 45-90 minutes prior to craniotomy and tumor resection.

Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 3 or 3 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4, 8, and 12 weeks, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Study Started
Jun 30
2000
Last Update
Nov 06
2013
Estimate

Drug carmustine in ethanol

Procedure conventional surgery

Criteria 

DISEASE CHARACTERISTICS:

Histologically confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI

Glioblastoma multiforme
Anaplastic ependymoma
Anaplastic astrocytoma
Anaplastic oligodendroglioma OR
Metastatic tumor to the brain other than melanoma
Planned resection of tumor (must be first surgery for recurrent disease)
Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no greater than 33.4 cm3

Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug

Tumor is spherical, spheroid, or ovoid
No tumors shaped into 3 or more components (e.g., multicentric or multilobulated)
No tumors extending into the ventricular system
Tumor has an intact stroma (i.e., tumor mass not partially incised or punctured)
Central necrosis and/or central cystic areas allowed if an enhancing rim with a thickness of more than 5 mm is present

No tumors in the following locations of the brain:

Brainstem (pons or medulla)
Midbrain (mesencephalon)
Primary sensorimotor cortex in the dominant hemisphere
Within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve

PATIENT CHARACTERISTICS:

Age:

18 to 75

Performance status:

Karnofsky 60-100%

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
No evidence of bleeding diathesis

Hepatic:

Bilirubin no greater than 2.0 mg/dL
SGOT and SGPT no greater than 2.5 times normal

Renal:

Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance at least 40 mL/min OR
BUN no greater than 30 mg/dL

Other:

No active uncontrolled infection
Afebrile (37.5 degrees C) unless fever due to tumor
No other unstable or severe medical condition
No complicating medical or psychiatric problem that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas, mitomycin, or Gliadel wafers) and recovered
No anti-tumor chemotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI

Endocrine therapy:

Not specified

Radiotherapy:

At least 4 weeks since prior radiotherapy and recovered
No prior intracranial brachytherapy
No anti-tumor radiotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI

Surgery:

See Disease Characteristics
Prior surgery allowed
No anti-tumor surgery within 12 weeks after study drug

Other:

No concurrent anticoagulants
No other concurrent investigational agents
No Results Posted