Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01505569 : Auto Transplant for High Risk or Relapsed Solid or CNS Tumors
PhaseN/A
AgesMin: N/A Max: 70 Years
Eligibility
Inclusion Criteria:

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

- Eligible Diseases

- Arm A: Solid Tumor

- 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

- Arm B: Certain CNS tumors

- Medulloblastoma: Children less than 36 months (3 years) of age at time of
definitive surgery (for histopathologic diagnosis) who have high risk
Medulloblastoma, defined as any one of the following:

1. > 1.5 cm2 residual disease following resection for any Medulloblastoma
histology

2. lumbar CSF cytology positive for tumor cells by analysis of fluid
collected either before definitive surgery or at least 10 days after
definitive surgery

3. MRI evidence of (a) gross nodular seeding in the intracranial
subarachnoid space or ventricular system distant from primary tumor
site, M2; or (b) gross nodular seeding in the spinal subarachnoid space
+/- evidence of intracranial seeding, M3; or (c) extraneural
metastases, M4,

- Anaplastic Histologic Variant Medulloblastoma: less than 70 years of age,
any metastatic stage, with total or sub-total resection.

- Infant Medulloblastoma: Children less than 8 months of age at the time of
definitive surgery (for histopathologic diagnosis), any histology, any
metastatic state, with total or sub-total resection.

- Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET): Children less than
36 months (3 years) of age at time of definitive surgery (for
histopathologic diagnosis) with or without metastatic disease

- Atypical Teratoid/Rhabdoid Tumor (AT/RT): less than 70 years of age with CNS
AT/RT (with or without metastatic disease).

- Other High Risk CNS Tumors - to be approved by 2 or more physicians (at
least one oncologist and one BMT physician).

- Arm C: Germ Cell Tumors

- Confirmation of germ cell tumor (GCT) histology (both seminoma and
nonseminoma). Tumor may have originated in any primary site. NOTE: In rare
circumstances, patients will be allowed to enroll even if a pathologic
diagnosis may not have been established. This would require a clinical
situation consistent with the diagnosis of GCT (testicular, peritoneal,
retroperitoneal or mediastinal mass, elevated tumor marker levels {HCG ?
500; AFP ? 500} and typical pattern of metastases).

1. One or more unfavorable prognostic features for achieving a CR with
conventional-dose chemotherapy. Unfavorable prognostic features
include:

2. extragonadal primary site

3. PD following an incomplete response (IR) to first-line therapy,

4. PD after a conventional-dose salvage (cisplatin + ifosfamide -based)
regimen

- Disease Status at Enrollment:

- Arms A & B, 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

- Arm C

- Evidence of progressive or recurrent GCT (measurable or non-measurable)
following one or more cisplatin-based chemotherapy, defined as meeting at
least one of the following criteria:

1. Tumor biopsy of new or growing or unresectable lesions demonstrating
viable non-teratomatous GCT. Patients with incomplete gross resection
where viable GCT is found are considered eligible.

2. Consecutive elevated serum tumor markers (HCG or AFP) that are
increasing. Increase of an elevated LDH alone does not constitute
progressive disease.

3. Development of new or enlarging lesions in the setting of persistently
elevated HCG or AFP, even if the HCG and AFP are not continuing to
increase.

- Age and Performance Status

- Arms A & B

- 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

- Arm C

- Age: 0-70 years of age

- Performance status: Karnofsky Performance Status ? 70% for patients > 16
years of age or Lansky Play Score ? 70 for patients ? 16 years of age

- Organ Function

- Arm A

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

- Renal: Glomerular Filtration Rate (GFR) ? 50 ml/min/1.73m^2 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)

- Arm B

- Timing: patients must be fully recovered from radiation, induction
chemotherapy or surgery prior to receiving consolidation, with minimum
elapsed time of 2 weeks.

- Hematologic: ANC > 750/µl, hemoglobin of >8 gm/dl (may receive PRBC
transfusions) and platelet count > 75,000/µl (transfusion independent).

- Renal: GFR ? 50 ml/min/1.73m^2

- Hepatic: AST or ALT ? 2.5 x ULN and bilirubin ? 1.5 x ULN

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

- Pulmonary: oxygen saturation > 94% at rest (on room air)

- Central Nervous System: patients with seizure history are allowed if on
anti-convulsants and well controlled; patients must not be in status
epilepticus, coma or require assisted ventilation

- Arm C

- Hematologic: ANC ? 750/mm^3, platelets ? 75,000/mm^3

- Renal: GFR ? 50 ml/min/1.73m2 or serum creatinine ? 2.5 x ULN for age

- Hepatic: AST or ALT ? 2.5 x upper limits of normal (ULN), if hepatic
involvement < 5 x ULN; bilirubin ? 2.0 x upper limits of normal (ULN)

- Arms A and C: Patients with a history of CNS tumor involvement are eligible if they
have completed treatment for CNS disease (radiotherapy or surgery or chemotherapy),
have recovered from or stabilization of the side effects associated with the therapy
and have no evidence of progressive CNS disease at the time of enrollment

Exclusion Criteria:

- Pregnant or breastfeeding

- Active, uncontrolled infection and/or human immunodeficiency virus (HIV) positive
constitute progressive disease.

- Concomitant enrollment on clinical study (such as COG study) that does not allow
co-enrollment on this standard of care protocol (Arm B only)
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01505569      |      Link to official Clinicaltrials.gov listing
Locations
Minneapolis, Minnesota
Facility: Masonic Cancer Center, University of Minnesota
Investigator: Heather Stefanski, MD, PhD
Contact: Kim Nelson Phone: 612-273-2925
Click HERE to send email to this center




Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2018 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740


Website Design By
World Wide Websites