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Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors


Phase 2
10 Years
69 Years
Open (Enrolling)
Both
Childhood Germ Cell Tumor, Ovarian Cancer, Teratoma

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Trial Information

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors


OBJECTIVES:

Primary

- Determine overall survival (OS) of patients with germ cell tumors treated with tandem
autologous stem cell transplantation with non-cross-resistant conditioning regimens.

Secondary

- Determine disease-free survival (DFS) of patients treated with this regimen.

- Determine the toxicity of tandem transplants

- Determine the time to engraftment of neutrophils and platelets in patients treated for
each transplant

- Determine the number of patients unable to adequately mobilize sufficient peripheral
blood stem cells (PBSC) for tandem transplantation.

- Identify prognostic factors of patients unlikely to mobilize sufficient PBSC for tandem
transplantation.

- Compare OS and DFS of patients undergoing single vs tandem transplantation.

OUTLINE:

- Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF): Patients
receive G-CSF subcutaneously (SC) beginning on day 1 and continuing until stem cell
collection is complete. Patients undergo stem cell collection beginning on day 5 of
G-CSF administration and continuing for at least 3 collections until the collection
goal is met.

- Second PBSC mobilization with chemotherapy: Patients not meeting the collection goal
receive cyclophosphamide IV over 2 hours on day 1 and G-CSF SC beginning on day 4 and
continuing until stem cell collection is complete. Patients meeting the collection goal
after PBSC mobilization via G-CSF alone or in combination with chemotherapy will
undergo tandem autologous transplantation. If collection goal is not met but the
patient has collected > or = 2 x 10^6 CD34 cells/kg, a single autologous transplant
will be performed.

- Single stem cell transplantation (SCT): Patients receive paclitaxel IV over 3 hours on
day -7 and ifosfamide IV on days -6 to -4. Patients undergo reinfusion of stem cells on
day 0. Patients also receive G-CSF SC or IV beginning on day 1 and continuing until
blood counts recover.

- Tandem SCT: Patients receive treatment as in single SCT. Beginning 30-90 days later,
patients receive carboplatin IV over 60 minutes and thiotepa IV over 30 minutes on days
-6 to -4 and etoposide IV over 60 minutes on days -6 to -3. Patients undergo reinfusion
of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 5 and
continuing until blood counts recover.

After completion of study treatment, patients are followed at 6, 9, and 12 months and then
every 6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.


Inclusion Criteria:



- Diagnosis: Poor Prognosis Non-Seminomas Germ Cell Tumor in ≥ PR1/CR1 or Good or
Intermediate Prognosis Seminomas and Non- Seminomas Germ Cell Tumor in ≥ PR1 or ≥ CR2
as defined by the International Germ Cell Cancer Consensus Classification. Patients
with increasing tumor markers only (i.e. no imaging evidence of progressive disease)
are eligible for transplant.

- Age: ≥ 10 years and < 70 years of age.

- Performance status: Karnofsky ≥ 80% (subjects ≥ 16 years of age) Lansky ≥ 80% for
subject 10 - 15 years of age

- Life expectancy: Greater than 8 weeks.

- Patients must have normal organ function as defined below:

- Hematologic:

- Hemoglobin > 8 gm/dL without transfusion and off erythropoietin for 14 days
or Aranesp for 21 days

- White blood cells (WBC) > 2.5 x 10^9/L with an absolute neutrophile count
(ANC) > 1.5 x 10^9/L and off G-CSF or GM-CSF for 10 days or Neulasta for 21
days

- Platelets > 100 x 10^9/L without transfusion and/or a bone marrow
cellularity of ≥ 20%

- Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min.

- Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper
limit of normal. No history of severe prior or ongoing chronic liver disease.

- Cardiac: Patients must be free of symptoms of uncontrolled cardiac disease
including unstable angina, decompensated congestive heart failure, or
arrhythmia. LVEF ≥45% by MUGA/ECHO.

- Pulmonary: Patients must have no significant obstructive airways disease (FEV1
must be ≥ 50% of predicted) and must have acceptable diffusion capacity
(corrected DLCO > 50% of predicted).

- 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:

- Patients with serious uncontrolled infections will not be eligible.

- Male and female patients of reproductive potential must use an approved contraceptive
method if appropriate (for example, intrauterine device [IUD], birth control pills,
or barrier device) during and for the duration of study participation. The drugs used
in this study are pregnancy category D - clear evidence of risk in pregnancy.

- Pregnant and breast feeding women will not be eligible.

Voluntary written informed consent before performance of any study-related procedure not
part of normal medical care, with the understanding that consent may be withdrawn by the
subject at any time without prejudice to future medical care.

Additional Eligibility prior to Transplant Two:

- Total Collection of ≥ 4 x 10^6 CD34 cells/kg prior to transplant one

- Transplant able to occur between day +30 and day +90 from transplant one

- Recovery of blood counts as demonstrated by:

- WBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 days

- Platelets > 50 x 10^9/L without transfusion in the prior 7 days

- Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min

- Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper
limit of normal

- Infection: Patients with serious uncontrolled infections at the time of planned
transplant will be excluded

- Patients with progressive disease by Response Evaluation Criteria in Solid Tumors
(RECIST) criteria by imaging techniques are not eligible to proceed to the second
transplant. Tumor marker increase alone is not sufficient to diagnose disease
progression.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival (OS)

Outcome Description:

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Brian McClune, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2006LS032

NCT ID:

NCT00432094

Start Date:

December 2006

Completion Date:

June 2014

Related Keywords:

  • Childhood Germ Cell Tumor
  • Ovarian Cancer
  • Teratoma
  • childhood extragonadal germ cell tumor
  • childhood malignant ovarian germ cell tumor
  • childhood malignant testicular germ cell tumor
  • stage III malignant testicular germ cell tumor
  • testicular choriocarcinoma and seminoma
  • testicular embryonal carcinoma and seminoma
  • testicular embryonal carcinoma and teratoma with seminoma
  • testicular embryonal carcinoma and yolk sac tumor with seminoma
  • testicular yolk sac tumor and teratoma with seminoma
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and teratoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma
  • testicular embryonal carcinoma and teratoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular embryonal carcinoma
  • testicular yolk sac tumor and teratoma
  • testicular yolk sac tumor
  • testicular seminoma
  • stage IV extragonadal non-seminomatous germ cell tumor
  • stage IV extragonadal seminoma
  • stage I extragonadal non-seminomatous germ cell tumor
  • stage I extragonadal seminoma
  • stage II extragonadal non-seminomatous germ cell tumor
  • stage II extragonadal seminoma
  • stage III extragonadal non-seminomatous germ cell tumor
  • stage III extragonadal seminoma
  • stage II ovarian germ cell tumor
  • stage I malignant testicular germ cell tumor
  • stage II malignant testicular germ cell tumor
  • adult teratoma
  • childhood teratoma
  • testicular immature teratoma
  • testicular mature teratoma
  • adult central nervous system germ cell tumor
  • childhood central nervous system germ cell tumor
  • Ovarian Neoplasms
  • Teratoma
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455