Treatment of Tumors of the Choroid Plexus Epithelium

NCT00500890 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2005-0398NCI-2012-01568
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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. Objectives: 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. 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. 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. 3.To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors.

Conditions

Choroid Plexus Tumors

Keywords

Choroid Plexus Tumors; Carboplatin; Cyclophosphamide; Etoposide; Vincristine; Paraplatin; Cytoxan; Neosar

Outcome Measures

Primary Outcomes (2)

• Main Phase (Started in 2006) Primary Specific Objective

  To compare the survival times after cyclophosphamide based treatment with survival times after carboplatin based treatment in chroid plexus tumors patients. For analysis, there will be no difference between death by tumor progression, treatment related (toxic) reasons or unrelated reasons.

  After randomization until the end of the observation or the death of the patient

• Secondary Objective SV40

  To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors. Prognosis of tumors with or without SV40 will be compared using overall survival time as endpoint. Kaplan Meier survival estimates and log rank tests as statistical methods similar to the analysis of primary objective.

  No data were collected due to early termination

Secondary Outcomes (2)

• Secondary Objective Resectability

  No data were collected due to early termination

• Secondary Objective Response

  No data were collected due to early termination

Study Arms (2)

Carboplatin + Etoposide + Vincristine

EXPERIMENTAL

Carboplatin 350 mg/m\^2 by vein, Over 2 Hours x 2 Days. Etoposide 100 mg/m\^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.

Drug: Carboplatin; Drug: Etoposide; Drug: Vincristine; Radiation: Radiation Therapy

Cyclophosphamide + Etoposide + Vincristine

EXPERIMENTAL

Cyclophosphamide 1 g/m\^2 by vein, Over 1 Hour x 2 Days. Etoposide 100 mg/m\^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.

Drug: Cyclophosphamide; Drug: Etoposide; Drug: Vincristine; Radiation: Radiation Therapy

Interventions

Carboplatin DRUG

350 mg/m\^2 by vein, Over 2 Hours x 2 Days

Also known as: Paraplatin

Carboplatin + Etoposide + Vincristine

Cyclophosphamide DRUG

1 g/m\^2 by vein, Over 1 Hour x 2 Days

Also known as: Cytoxan, Neosar

Cyclophosphamide + Etoposide + Vincristine

Etoposide DRUG

100 mg/m\^2 by vein, Over 1 Hour x 5 Days

Carboplatin + Etoposide + Vincristine; Cyclophosphamide + Etoposide + Vincristine

Vincristine DRUG

1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5

Carboplatin + Etoposide + Vincristine; Cyclophosphamide + Etoposide + Vincristine

Radiation Therapy RADIATION

Radiation treatment over a period of about 6 weeks.

Also known as: RT, XRT, Radiotherapy

Carboplatin + Etoposide + Vincristine; Cyclophosphamide + Etoposide + Vincristine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The reference center has confirmed the receipt of slides sent (For randomization only = form 2)
• The postoperative imaging has been done and the result is available (for randomization only = for form 2 only)
• Indication criteria: Choroid plexus papilloma (Gr I) with histologically confirmed metastases. (For randomization only = use form 2).
• Indication criteria: Atypical choroid plexus papilloma or anaplastic choroid plexus papilloma histology with either metastases or postoperative residual tumor. (For randomization only = use form 2).
• Indication criteria: Choroid plexus carcinoma, regardless of histologically confirmed metastases or residual tumor. (For randomization only = use form 2).
• Informed consent signed (required for registration = form 1, and for randomization = form 2)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Wrede B, Hasselblatt M, Peters O, Thall PF, Kutluk T, Moghrabi A, Mahajan A, Rutkowski S, Diez B, Wang X, Pietsch T, Kortmann RD, Paulus W, Jeibmann A, Wolff JEA. Atypical choroid plexus papilloma: clinical experience in the CPT-SIOP-2000 study. J Neurooncol. 2009 Dec;95(3):383-392. doi: 10.1007/s11060-009-9936-y. Epub 2009 Jun 20.

  PMID: 19543851 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Choroid Plexus Neoplasms

Interventions

Carboplatin; Cyclophosphamide; Etoposide; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Cerebral Ventricle Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Results Point of Contact

• Title: Dr. Richard Gorlick, MD/Division Head, Pediatrics Administration
• Organization: UT MD Anderson Cancer Center

rgorlick@mdanderson.org

713- 563-2516

Study Officials

• Michael E. Rytting, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2007
• First Posted: July 13, 2007
• Study Start: September 2, 2005
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Locations

US (1)