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A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors


Phase 1
1 Year
45 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Chordoma, Kidney Cancer, Liver Cancer, Neuroblastoma, Ovarian Cancer, Retinoblastoma, Sarcoma

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Trial Information

A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors


OBJECTIVES:

- Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral
blood stem cell transplantation plus chemotherapy in patients with high-risk or
relapsed solid tumors or brain tumors.

- Determine response or time to disease progression in patients treated with this
regimen.

OUTLINE: This is a dose-escalation study of amifostine. Patients are stratified according to
age (1 to 18 vs 19 to 45 years).

All patients receive filgrastim (G-CSF) IV for 1 week. On day 6 of G-CSF administration,
patients undergo peripheral blood stem cell (PBSC) harvest followed by chemotherapy.

Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over
30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2. Patients
receive amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa
administration on days -5 to -1. PBSC are reinfused on day 0.

Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated
dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

Patients are followed on day 50; at 3, 6, and 9 months; and at 1, 2, and 3 years post PBSC
transplantation.

PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study
within 3 years.


Inclusion Criteria:



- Histologically confirmed high-risk or relapsed solid tumors or brain tumors,
including:

- Metastatic or relapsed Ewing's sarcoma

- Metastatic or relapsed rhabdomyosarcoma

- Refractory Wilms' tumor

- Diffuse anaplastic Wilms' tumor

- Stage III or IV neuroblastoma

- Recurrent retinoblastoma

- Metastatic or relapsed germ cell tumors

- Metastatic or relapsed other soft tissue sarcomas

- Small cell ovarian sarcoma

- Metastatic or relapsed primitive neuroectodermal tumors of the bone

- Recurrent brain tumors

- Desmoplastic small round cell tumors

- Recurrent or metastatic chordomas

- Metastatic or relapsed hepatoblastoma

- Patients receive peripheral blood stem cell transplantation only if in complete
remission or in very good partial remission with no disease progression

- Must have radiologic, nuclear image, or histologic verification of relapse

- Age 1 to 45

- Performance status:Karnofsky 70-100%

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin count at least 10 g/dL

- Bilirubin less than 2 times upper limit of normal (ULN)

- SGOT or SGPT less than 2.5 times ULN

- Creatinine less than 2 times ULN

- Creatinine clearance greater than 70 mL/min

- Cardiac shortening fraction greater than 30%

- Cardiac ejection fraction greater than 45%

- At least 1 week since prior hematopoietic growth factor and recovered

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- Recovered from any prior therapy

Exclusion Criteria:

- Osteogenic sarcoma

- Less than 4 months

- Uncontrolled bleeding

- Congestive heart failure

- Uncontrolled hypertension

- Asthma

- Pregnant or nursing

- Uncontrolled metabolic disease

- Active severe infection

- Allergy to aminothiol compounds

- Prior bone marrow transplantation

- Other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

John P. Perentesis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

1997LS053

NCT ID:

NCT00003926

Start Date:

November 1998

Completion Date:

August 2003

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Chordoma
  • Kidney Cancer
  • Liver Cancer
  • Neuroblastoma
  • Ovarian Cancer
  • Retinoblastoma
  • Sarcoma
  • soft tissue sarcoma
  • regional neuroblastoma
  • disseminated neuroblastoma
  • recurrent Wilms tumor
  • recurrent retinoblastoma
  • recurrent adult brain tumor
  • adult rhabdomyosarcoma
  • ovarian germ cell tumor
  • chordoma
  • ovarian sarcoma
  • unresectable neuroblastoma
  • desmoplastic small round cell tumor
  • rhabdomyosarcoma
  • Ewing sarcoma
  • neuroectodermal tumor
  • teratoma
  • malignant testicular germ cell tumor
  • malignant ovarian germ cell tumor
  • extragonadal germ cell tumor
  • malignant germ cell tumor
  • hepatoblastoma
  • liver cancer
  • medulloblastoma
  • cerebellar astrocytoma
  • brain stem glioma
  • glioma
  • cerebral astrocytoma
  • ependymoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Chordoma
  • Liver Neoplasms
  • Nervous System Neoplasms
  • Neuroblastoma
  • Ovarian Neoplasms
  • Retinoblastoma
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Sarcoma

Name

Location
University of Minnesota Cancer Center Minneapolis, Minnesota  55455