MDACC Study Summary 2005-0398

Study Summary
No. 2005-0398:.......Pediatrics; Solid Tumors......Michael E. Rytting......Pediatrics

Study Summary Title



Study Summary Number:	2005-0398

Study Title:	A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients with Choroid Plexus Tumors.

Physician

New Patient Referral



Name:	Michael E. Rytting	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0774 Contact us about clinical trials

General Information



Disease Group:	Pediatrics Solid Tumors	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Patients that require chemotherapy will receive treatment for 5 days per course with 4 weeks interval for total of 6 courses in both arms.

Treatment Agents:	Carboplatin Cyclophosphamide Etoposide Vincristine	Home Care:	NONE.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Treatment can be administered both in an outpatient and inpatient basis for each cycle and during the recovery period after surgery.


Description/ Intervention:	The goal of this clinical research study is to compare carboplatin to cyclophosphamide when given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus tumors. The safety of these 2 combination therapies will also be compared.

Study Objectives / Outcomes

OVERALL AIM

To improve choroid plexus tumor treatment through better understanding of the tumor biology and through increased knowledge about the benefit of specific treatment elements.

Specific Objectives:

The study will have a prephase to evaluate the feasibility of the following randomized study (main phase).

Pre-Phase (completed 2005) Primary Specific Objective:
To determine the number of patients accountable per year for randomization in a worldwide study.

Secondary Specific Objective:
To measure the number of drop outs and to describe the toxicity of the chemotherapy.

Main Phase (started in 2006) Primary Specific Objective:
To compare the survival times after cyclophosphamide based treatment with the survival times after carboplatin based treatment in choroid plexus tumor patients.

Main Phase Secondary Specific Objectives:

1. To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based treatment with the resectability after two blocks of carboplatin based treatment.
2. To compare response rates of incompletely resected choroid plexus tumors to two blocks of cyclophosphamide based treatment with the response rates after two blocks of carboplatin based treatment.
3. To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors.

Study Status Information



Study Activation / Registration Date:	09/02/2005

IRB Review and Approval Date:	08/03/2005

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	100

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) The reference centre has confirmed the receipt of slides sent (For randomization only = form 2)

2) The postoperative imaging has been done and the result is available (for randomization only = for form 2 only)

3) Indication criteria: Choroid plexus papilloma (Gr I) with histologically confirmed metastases. (For randomization only = use form 2).

4) Indication criteria: Atypical chorod plexus papilloma or anaplastic choroid plexus papilloma histology with either metastases or postoperative residual tumor. (For randomization only = use form 2).

5) Indication criteria: Choroid plexus carcinoma, regardless of histologically confirmed metastases or residual tumor. (For randomization only = use form 2).

6) Informed consent signed (required for registration = form 1, and for randomization = form 2)

7) Patients must have the following: WBC > 2000/ul, platelets >85 000/ul, serum creatinine in normal range, pregnancy test negative, hearing loss less than 30dB at 3000 Hz.

Exclusion Criteria:

1) Previous irradiation or chemotherapy. (Exclusion from randomization only)

2) The protocol did not pass the local centre required approvals, such as the Ethics Committee or the scientific review.

3) Previous immunotherapy or antiangiogenic therapy (Exclusion from randomization only)

Links

Registration Number: NCT00500890
Study Information on Clinical Trials Registry (clinicaltrials.gov)