Clinical trial · Interventional

Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer

Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers

NCT00002515CI-TRIAL-00011016completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer.

Conditions

Conditions (11)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Childhood Germ Cell Tumor	Childhood Germ Cell Tumor	ONTOLOGY_EXACT	0.98
Extragonadal Germ Cell Tumor	Extragonadal Germ Cell Tumor	ONTOLOGY_EXACT	0.98
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Kidney Cancer	Malignant Kidney Neoplasm	CURATED_EXACT	0.92
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Retinoblastoma	Retinoblastoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
autologous bone marrow transplantation	Procedure	—	UNRESOLVED
bone marrow ablation with stem cell support	Procedure	—	UNRESOLVED
carboplatin	Drug	Carboplatin	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
in vitro-treated bone marrow transplantation	Procedure	—	UNRESOLVED
thiotepa	Drug	Thiotepa	ALIAS
topotecan hydrochloride	Drug	Topotecan	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 21 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed malignancy of one of the following types:

  * Wilms' tumor
  * Liver cancer
  * Desmoplastic or other small round cell tumor
  * Nasopharyngeal carcinoma
  * Fibrosarcoma
* Disease that has metastasized and has a cure rate of no greater than 25% with conventional treatment or disease that has progressed after prior chemotherapy, was not then surgically resectable, and has a salvage rate with nonmyeloablative therapies of no greater than 25% required
* Maximal benefit from conventional (nonmyeloablative) doses of combination chemotherapy required prior to entry, and it is recommended that patients have received a minimum of one of the following:

  * 2 courses of high-dose cyclophosphamide (as per protocol MSKCC-90062)
  * 2 courses of high-dose ifosfamide/etoposide (as in the poor-risk sarcoma protocol MSKCC-90071A)
  * 1 course of high-dose cyclophosphamide plus 1 course of high-dose ifosfamide/etoposide
* Within 3 weeks of initiation of protocol therapy, patients must be:

  * In CR or good PR OR
  * Tumor considered "chemosensitive", i.e., a 50% or greater decrease in at least 1 measurable tumor parameter attributable to prior chemotherapy without evidence of progressive disease by any other parameter
* Ineligible for other IRB-approved myeloablative regimens
* No evidence of current bone marrow involvement on bone marrow aspiration (x4) and biopsy (x2)

PATIENT CHARACTERISTICS:

Age:

* 21 and under

Performance status:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 1.5 times ULN
* 5'-Nucleotidase no greater than 1.5 times ULN

Renal:

* Creatinine normal
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* CPK normal
* Echocardiogram (or RNCA) normal
* EKG normal

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Oct 1, 1992
Primary completion: Apr 1, 2005
Completion: Apr 1, 2005
First posted: Jan 27, 2003
Last update posted: Jun 24, 2013
Lead sponsor: Memorial Sloan Kettering Cancer Center OTHER
Keywords: chondrosarcoma, recurrent childhood rhabdomyosarcoma, stage IV childhood liver cancer, recurrent neuroblastoma, recurrent childhood liver cancer, recurrent Wilms tumor and other childhood kidney tumors, stage IV Wilms tumor, recurrent retinoblastoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent osteosarcoma, stage IV ovarian germ cell tumor, recurrent malignant testicular germ cell tumor, childhood germ cell tumor, alveolar childhood rhabdomyosarcoma, recurrent childhood soft tissue sarcoma, recurrent ovarian germ cell tumor, childhood fibrosarcoma, extragonadal germ cell tumor, childhood desmoplastic small round cell tumor, recurrent childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, stage IV childhood large cell lymphoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx

Data updated 22 days agoSource updated Jun 24, 2013source: clinicaltrials

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