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High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy


Phase 2
N/A
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer, Retinoblastoma, Testicular Germ Cell Tumor, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy


OBJECTIVES:

- Evaluate the efficacy and toxicity of sequential cycles of high dose thiotepa with stem
cell rescue and filgrastim in patients with malignancies refractory to conventional
chemotherapy or for whom conventional therapy is not available.

- Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis
following high dose thiotepa.

OUTLINE: Patients are stratified by type of tumor (neuroectodermal CNS tumor vs
non-neuroectodermal CNS tumor vs non-CNS small round blue cell tumor vs other non-CNS
tumor).

Autologous stem cells are obtained prior to the administration of thiotepa. Patients who do
not have peripheral blood stem cells available may undergo a bone marrow harvest instead.
Thiotepa is administered as a 3 hour infusion daily for 3 consecutive days. Stem cells are
reinfused approximately 72 hours following the completion of thiotepa. Filgrastim is
administered the day following reinfusion of stem cells and continues until there is
sufficient hematopoietic recovery.

The second course of thiotepa is administered 4 weeks following the first course in patients
who have responding or stable disease, adequate stem cells, and no unacceptable toxicity.
Patients receive a maximum of 2 courses.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Malignant solid tumors

- Must have failed conventional treatment or for whom conventional therapy is not
available

- Measurable disease by MRI or CT scan

- Intraocular retinoblastomas may be measured by direct visualization

- Germ cell tumors may be measured by tumor markers

- No known bone marrow involvement

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- Lansky 60-100% for patients 16 and under

- Karnofsky 60-100% for patients over 16

Life expectancy:

- At least 8 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3

- If parameters not met, must have adequate stem cell yield

Hepatic:

- Bilirubin no greater than 1.5 times the upper limit of normal (ULN)

- SGOT and SGPT no greater than 2.5 times the ULN (unless liver involvement by tumor)

Renal:

- Creatinine within normal limits OR

- Creatinine clearance at least 70 mL/min

Cardiovascular:

- Fractional shortening greater than 28% on echocardiogram OR

- Ejection fraction at least 55% on RNCA prior to first cycle of thiotepa

Pulmonary:

- DLCO greater than 55% of predicted (only required if there is clinical evidence of
pulmonary dysfunction)

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior bone marrow or peripheral blood stem cell rescue allowed

Chemotherapy:

- At least 4 weeks since prior chemotherapy if absolute neutrophil count is less than
1,000/mm^3 or platelet count is less than 75,000/mm^3, and recovered (i.e. adequate
stem cells collected to predict hematopoietic recovery)

- No concurrent chemotherapy except for dexamethasone for antiedema effects

Endocrine therapy:

- No concurrent use of corticosteroids used solely as antiemetics

Radiotherapy:

- At least 4 weeks since radiotherapy if absolute neutrophil count is less than
1,000/mm^3 or platelet count is less than 75,000/mm^3, and recovered (i.e. adequate
stem cells collected to predict hematopoietic recovery)

- No concurrent radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ira Dunkel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

97-089

NCT ID:

NCT00003173

Start Date:

September 1997

Completion Date:

May 2003

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Retinoblastoma
  • Testicular Germ Cell Tumor
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • intraocular retinoblastoma
  • recurrent retinoblastoma
  • childhood central nervous system germ cell tumor
  • stage III malignant testicular germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • unspecified childhood solid tumor, protocol specific
  • unspecified adult solid tumor, protocol specific
  • childhood germ cell tumor
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • extragonadal germ cell tumor
  • adult central nervous system germ cell tumor
  • childhood teratoma
  • childhood malignant testicular germ cell tumor
  • childhood malignant ovarian germ cell tumor
  • childhood extragonadal germ cell tumor
  • recurrent childhood malignant germ cell tumor
  • Nervous System Neoplasms
  • Ovarian Neoplasms
  • Retinoblastoma
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016