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Alkylator-Intense Conditioning Followed by Autologous Transplantation for Patients With High Risk or Relapsed Solid Tumor


N/A
N/A
70 Years
Open (Enrolling)
Both
Hematopoietic Stem Cell Transplantation, Solid Tumor, Transplantation, Autologous

Thank you

Trial Information

Alkylator-Intense Conditioning Followed by Autologous Transplantation for Patients With High Risk or Relapsed Solid Tumor


Inclusion Criteria:



All patients must have histological verification of malignancy at original diagnosis.

- Eligible Diseases

- Ewing's Family Tumors (ES/PNET/DSRCT) - metastatic at time of diagnosis and/or
relapsed after therapy

- Renal Tumors - relapsed (all histology - Wilm's tumor) or at diagnosis (clear
cell sarcoma and Rhabdoid tumor)

- Hepatoblastoma - metastatic at time of diagnosis and/or relapsed after therapy

- Rhabdomyosarcoma - metastatic at time of diagnosis and/or relapsed after therapy

- Soft Tissue Sarcoma - chemotherapy responsive metastatic disease or chemotherapy
responsive relapsed disease

- Primary Malignant Brain Neoplasms <18 years of age - at diagnosis and/or relapse

- Retinoblastoma - disseminated at diagnosis and/or relapsed

- Other High Risk Metastatic or Relapsed Solid Tumors - to be approved by 2 or
more pediatric hematology/oncology and bone marrow transplant (BMT) physicians

- Disease Status at Enrollment must have fit one of the following:

- no evidence of disease or

- stable, non-progressive disease (defined as non-progressive abnormalities on
physical exam or CT and/or MRI) within 4 weeks of study entry

- Age and Performance Status

- Age: 0 - 70 years

- Performance status: Karnofsky Performance Status at least 50% for patients > 16
years of age or Lansky Play Score at least 50 for patients less than or equal to
16 years of age. (Note: Neurologic deficits in patients with central nervous
system (CNS) tumors must be stable for a minimum of 1 week prior to study entry

- Organ Function

- Hematologic: hemoglobin of >9 gm/dl and platelet count > 20,000/μl. Patients may
receive transfusions as necessary.

- Renal: Glomerular Filtration Rate (GFR) ≥ 50 ml/min/1.73m2 or serum creatinine ≤
2.5 x upper limit of normal (ULN) for age

- Hepatic: aspartate aminotransferase or alanine aminotransferase (AST or ALT) ≤ 5
x ULN and bilirubin ≤ 5 x ULN

- Cardiac: ejection fraction ≥ 45% or no clinical evidence of heart failure

- Pulmonary: oxygen saturation > 92% at rest (on room air)

Exclusion Criteria:

- Pregnant or breastfeeding

- Active, uncontrolled infection and/or human immunodeficiency virus (HIV) positive

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Number of patients who have received autologous transplant for high risk or relapsed solid tumor and are alive at 1 year.

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Michael Verneris, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2011OC057

NCT ID:

NCT01505569

Start Date:

October 2011

Completion Date:

December 2016

Related Keywords:

  • Hematopoietic Stem Cell Transplantation
  • Solid Tumor
  • Transplantation, Autologous
  • autologous transplantation
  • high risk solid tumor
  • relapsed solid tumor
  • Neoplasms

Name

Location

Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455