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Brain and Central Nervous System TumorsPhase 1NCT00007813

Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors

A Phase 1 study testing filgrastim, carboplatin and cyclophosphamide in people with Brain and Central Nervous System Tumors and Childhood Germ Cell Tumor, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages Up to 35 years
What is being tested?
filgrastim, carboplatin and cyclophosphamide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
31 May 1997to 1 Feb 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically proven malignant solid tumor, including any of the following:
  • Rhabdomyosarcoma
  • Neuroblastoma
  • Ewing's sarcoma/primitive neuroectodermal tumor
  • Germ cell tumors
  • Childhood brain tumors
  • Hepatoblastoma
  • Metastatic disease OR has failed at least first-line therapy
  • Ineligible for higher priority protocols

PATIENT CHARACTERISTICS:

Age:

  • Under 36 at transplantation

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 75,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Liver function tests no greater than 2 times normal OR
  • No active hepatitis on liver biopsy
  • No hepatitis B infection

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Glomerular filtration rate (preferably measured) greater than 60% of normal

Cardiovascular:

  • Left ventricular ejection fraction at least 45%
  • No active congestive heart failure
  • No active arrhythmia

Pulmonary:

  • Age 8 and under: clinically normal pulmonary function
  • Over age 8: FEV1 and FVC at least 50% predicted
  • Arterial blood gases normal and DLCO at least 50% if spirograms difficult to
  • interpret due to poor patient effort, recent surgery, or pulmonary tumor
  • involvement

Other:

  • No mucositis or mucosal infection prior to myeloablative chemotherapy
  • HIV negative
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

Official title: TREATMENT OF CHILDREN AND YOUNG ADULTS WITH RECURRENT/REFRACTORY SOLID TUMORS WITH HIGH DOSE ETOPOSIDE AND CARBOPLATIN PLUS ESCALATING DOSE CYCLOPHOSPHAMIDE, FOLLOWED BY HEMATOPOIETIC RESCUE USING AUTOLOGOUS CD34+ SELECTED BLOOD STEM CELLS: A PILOT STUDY

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide when given together with combination chemotherapy and a peripheral stem cell transplant in treating patients with malignant solid tumors.

Read the detailed description

OBJECTIVES:

  • Determine whether autologous transplantation of mobilized CD34+ peripheral blood stem cells (PBSC) can provide complete hematologic reconstitution after myeloablative chemotherapy comprising etoposide (VP-16) and carboplatin (CBDCA) in patients with metastatic or recurrent rhabdomyosarcoma, neuroblastoma, Ewing's sarcoma/primitive neuroectodermal tumor, germ cell tumors, childhood brain tumors, or hepatoblastoma.
  • Determine the frequency and yield of CD34+ PBSC and granulocyte-macrophage colony-forming units (GM-CFU) that are mobilized, harvested, and purified after a single priming course of high-dose cyclophosphamide (CTX) followed by filgrastim (G-CSF).
  • Correlate the number of CD34+ cells and GM-CFU in the autologous PBSC graft with time to engraftment of white blood cells, neutrophils, and platelets in these patients.
  • Determine the optimal day of PBSC harvest after a single priming course of high-dose CTX and G-CSF in these patients.
  • Determine whether CD34+ PBSC rescue and daily post-transplantation G-CSF decrease the time to hematopoietic recovery after high-dose VP-16 and CBDCA compared to historical results achieved in similar patients rescued with bone marrow.
  • Compare the tumor cell content of marrow, mobilized blood, and purified CD34+ PBSC graft preparations.
  • Determine the optimal timing of PBSC mobilization and harvest in relation to extent of prior chemotherapy in these patients.
  • Determine the feasibility of a single leukapheresis for PBSC harvest in children.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of cyclophosphamide.

Mobilization/harvest: Patients receive cyclophosphamide IV over 90 minutes on day 0 and filgrastim (G-CSF) subcutaneously or IV over 30 minutes on days 2-15 or until blood counts recover. Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells on day 15. Bone marrow is also harvested in case insufficient PBSC are harvested.

Preparative regimen/transplantation: Patients receive carboplatin IV over 1 hour and etoposide IV continuously on days -6 to -4. Cyclophosphamide is administered IV over 1 hour on days -3 and -2 or IV continuously on days -3 and -2, -4 to -2, -5 to -2, or -6 to -2. PBSC or bone marrow is reinfused on day 0.

Cohorts of 3-10 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 20% of patients experience dose-limiting toxicity.

At least 6 additional patients receive cyclophosphamide at the MTD.

PROJECTED ACCRUAL: A minimum of 36 patients will be accrued for this study.

Being tested
filgrastim, carboplatin, cyclophosphamide, etoposide, autologous bone marrow transplantation
Keywords
recurrent childhood rhabdomyosarcoma, childhood craniopharyngioma, recurrent childhood brain tumor, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage IV childhood liver cancer, recurrent childhood liver cancer, childhood hepatoblastoma, childhood central nervous system germ cell tumor, stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, childhood germ cell tumor, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, extragonadal germ cell tumor, childhood oligodendroglioma, childhood choroid plexus tumor, childhood grade III meningioma, recurrent childhood cerebellar astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Liver Neoplasms, Neuroblastoma, Ovarian Neoplasms, Sarcoma, Testicular Germ Cell Tumor, Hepatoblastoma, Testicular Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00007813
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Biological: filgrastim; Drug: carboplatin; Drug: cyclophosphamide; Drug: etoposide; Procedure: autologous bone marrow transplantation; Procedure: peripheral blood stem cell transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2004 (estimated)
  2. Study start31 May 1997
  3. Primary completion1 Feb 2005
  4. Study completion1 Feb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00007813
Sponsor's protocol ID
JHOC-9512
Other IDs
CDR0000064263, NCI-V95-0688, 94-12-23-02
Status last verified
Feb 2020
First submitted
6 Jan 2001
Last updated
17 Feb 2020
Results posted
No

Publications

  • Leung W, Chen AR, Klann RC, et al.: Tumor cells frequently detected in marrow and mobilized blood hematopoietic grafts in neuroblastoma and primitive neuroblastoma and primitive neuroectodermal tumor: purging by immunomagnetic CD34+ cell selection. [Abstract] Blood 88: A-1917, 482a, 1996.

  • Chen AR, Cohen KJ, Eby LL, et al.: Heterogenous mobilization of CD34+ blood stem cells for autologous rescue of children with poor prognosis solid tumors. [Abstract] Blood 86: 403a, 1995.

  • Chen AR, Wiangon S, Noga SJ, et al.: Rapid engraftment of CD34+ selected peripheral blood stem cells (PBSC) after high-dose chemotherapy for patients with recurrent, refractory, or metastatic pediatric solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A2038, 530a, 1998.

  • Leung W, Chen AR, Klann RC, Moss TJ, Davis JM, Noga SJ, Cohen KJ, Friedman AD, Small D, Schwartz CL, Borowitz MJ, Wharam MD, Paidas CN, Long CA, Karandish S, McMannis JD, Kastan MB, Civin CI. Frequent detection of tumor cells in hematopoietic grafts in neuroblastoma and Ewing's sarcoma. Bone Marrow Transplant. 1998 Nov;22(10):971-9. doi: 10.1038/sj.bmt.1701471.

    PubMed 9849694

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing filgrastim, carboplatin and cyclophosphamide in people with Brain and Central Nervous System Tumors and Childhood Germ Cell Tumor, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00007813, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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