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Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers


Phase 2
N/A
21 Years
Not Enrolling
Both
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Head and Neck Cancer, Kidney Cancer, Liver Cancer, Lymphoma, Neuroblastoma, Ovarian Cancer, Retinoblastoma, Sarcoma, Testicular Germ Cell Tumor

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Trial Information

Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers


OBJECTIVES:

- Improve the long term disease-free survival of patients with rare cancers at high risk
for lethal relapse by using myeloablative chemotherapy with thiotepa, carboplatin, and
topotecan followed by autologous bone marrow or peripheral blood stem cell rescue.

OUTLINE: Autologous bone marrow or peripheral blood stem cells (PBSC) are harvested.
Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6, carboplatin IV over 4
hours on days -5 to -3, and topotecan IV over 30 minutes on days -8 to -4. Autologous bone
marrow or PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) IV twice daily
beginning on day 1.

Patients are followed for 1 year.

PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignancy of one of the following types:

- Wilms' tumor

- Liver cancer

- Desmoplastic or other small round cell tumor

- Nasopharyngeal carcinoma

- Fibrosarcoma

- Disease that has metastasized and has a cure rate of no greater than 25% with
conventional treatment or disease that has progressed after prior chemotherapy, was
not then surgically resectable, and has a salvage rate with nonmyeloablative
therapies of no greater than 25% required

- Maximal benefit from conventional (nonmyeloablative) doses of combination
chemotherapy required prior to entry, and it is recommended that patients have
received a minimum of one of the following:

- 2 courses of high-dose cyclophosphamide (as per protocol MSKCC-90062)

- 2 courses of high-dose ifosfamide/etoposide (as in the poor-risk sarcoma
protocol MSKCC-90071A)

- 1 course of high-dose cyclophosphamide plus 1 course of high-dose
ifosfamide/etoposide

- Within 3 weeks of initiation of protocol therapy, patients must be:

- In CR or good PR OR

- Tumor considered "chemosensitive", i.e., a 50% or greater decrease in at least 1
measurable tumor parameter attributable to prior chemotherapy without evidence
of progressive disease by any other parameter

- Ineligible for other IRB-approved myeloablative regimens

- No evidence of current bone marrow involvement on bone marrow aspiration (x4) and
biopsy (x2)

PATIENT CHARACTERISTICS:

Age:

- 21 and under

Performance status:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

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

- SGOT no greater than 1.5 times ULN

- Alkaline phosphatase no greater than 1.5 times ULN

- 5'-Nucleotidase no greater than 1.5 times ULN

Renal:

- Creatinine normal

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- CPK normal

- Echocardiogram (or RNCA) normal

- EKG normal

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian H. Kushner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

92-148

NCT ID:

NCT00002515

Start Date:

October 1992

Completion Date:

April 2005

Related Keywords:

  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Head and Neck Cancer
  • Kidney Cancer
  • Liver Cancer
  • Lymphoma
  • Neuroblastoma
  • Ovarian Cancer
  • Retinoblastoma
  • Sarcoma
  • Testicular Germ Cell Tumor
  • chondrosarcoma
  • recurrent childhood rhabdomyosarcoma
  • stage IV childhood liver cancer
  • recurrent neuroblastoma
  • recurrent childhood liver cancer
  • recurrent Wilms tumor and other childhood kidney tumors
  • stage IV Wilms tumor
  • recurrent retinoblastoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent osteosarcoma
  • stage IV ovarian germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • childhood germ cell tumor
  • alveolar childhood rhabdomyosarcoma
  • recurrent childhood soft tissue sarcoma
  • recurrent ovarian germ cell tumor
  • childhood fibrosarcoma
  • extragonadal germ cell tumor
  • childhood desmoplastic small round cell tumor
  • recurrent childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Head and Neck Neoplasms
  • Liver Neoplasms
  • Lymphoma
  • Neuroblastoma
  • Ovarian Neoplasms
  • Retinoblastoma
  • Neoplasms, Germ Cell and Embryonal
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021