Aflac ST0901 CHOANOME

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-08-09

Brief Summary

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The best treatment for recurrent cancers or those that do not respond to therapies is not known. Typically, patients with these cancers receive a combination of cancer drugs (chemotherapy), surgery, or radiation therapy. These treatments can prolong their life but may not offer a long-term cure.

This study proposes using a drug called Sirolimus in combination with common chemotherapy drugs to treat patients with recurrent and refractory solid tumors. Sirolimus has been found to inhibit cell growth and to have anti-tumor activity in pediatric solid tumors in previous studies and, therefore, has the potential to increase the effectiveness of the chemotherapy drugs when given together.

This study wil investigate the highest dose of Sirolimus that can be given orally with other oral chemotherapy drugs. Cohorts of 2 subjects will be started at the minimum dose. The dose will be increased in the next 2 subjects as long as there were no major reactions in the previous groups. This study will also seek to learn more about the side effects of sirolimus when used in this combination and what effects the drug has on the white cells and the immune system. Successful use of this drug will impact the cancer population greatly by providing an increased chance of survival to those with resistant or recurrent cancers.

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Detailed Description

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Sirolimus, is a potent immunosuppressive drug that is approved for use in prevention against allograft rejection following solid organ transplant. It has anti-tumor effects mainly by blocking signals which drive cells from G1 to S phase during cell cycle through inhibition of mTOR, thus inhibiting cell growth. Sirolimus, as well as other mTOR inhibitors, has shown anti-tumor activity in pediatric solid tumor xenografts. Children with relapsed and/or refractory solid tumors are in need of novel therapeutic approaches. One option for these patients is the use of prolonged exposure to low dose antiangiogenic chemotherapy, with agents such as etoposide and cyclophosphamide. In this phase I trial the feasibility and optimal dosing for daily sirolimus, in combination with daily celecoxib, and low dose etoposide alternating with cyclophosphamide, will be determined in children with relapsed and refractory solid tumors. p70S6 kinase inhibition will be used as a surrogate for mTOR inhibition. The potential immunosuppressive effect of sirolimus administered on this schedule will be assessed by serial lymphocyte subsets and assessment of memory T cell number.

Conditions

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Ewing's Sarcoma Osteosarcoma Astrocytoma Atypical Teratoid/Rhabdoid Tumor Ependymoma Germ Cell Tumor Glioma Medulloblastoma Rhabdoid Tumor Retinoblastoma Clear Cell Sarcoma Renal Cell Carcinoma Wilms Tumor Hepatoblastoma Neuroblastoma Rhabdomyosarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sirolimus treatment

Dose escalation of sirolimus with starting dose at 1 mg/m2 and increasing to a possible 3 mg/m2.

Group Type EXPERIMENTAL

sirolimus

Intervention Type DRUG

daily administration of sirolimus in oral form starting at a dose of 1 mg/m2 and increasing to a possible 3 mg/m2.

Interventions

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sirolimus

daily administration of sirolimus in oral form starting at a dose of 1 mg/m2 and increasing to a possible 3 mg/m2.

Intervention Type DRUG

Other Intervention Names

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rapamune cypher renacept

Eligibility Criteria

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Inclusion Criteria

* must be \<=30 years of age at time of study enrollment
* histologic verification of malignancy at original diagnosis or relapsis except in patients with intrinsic brain stem tumors, optic pathway gliomas or patients wtih pineal tumors and evaluations of serum or CSF alpha-fetoprotein or beta-HCG
* measurable or evaluable disease
* disease state must be one for which there is no known curative therapy
* Performance level \>=50%
* Patients must have fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
* no evidence of acute graft vs. host disease and \>=3 months since transplant
* organ function as defined in eligibility section of protocol

Exclusion Criteria

* patients cannot be pregnant or breast-feeding
* patients must agree to use of an effective contraceptive method
* no growth factors that support platelet or white cell number or function for at least 7 days prior to enrollment
* patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days are not eligible
* patients receiving any other investigational drugs
* patients receiving any other anti-cancer drugs
* patients who have an uncontrolled infection

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No