Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies (NYMC195)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04308330|
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : August 6, 2020
Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy.
The goals of this study are:
- To find the highest safe dose of vorinostat that can be given together with vincristine, irinotecan, and temozolomide without causing severe side effects;
- To learn what kind of side effects this four drug combination can cause;
- To learn about the effects of vorinostat and the combination of vorinostat, vincristine, irinotecan, and temozolomide on specific molecules in tumor cells;
- To determine whether the combination of vorinosat, vincristine, irinotecan, and temozolomide is a beneficial treatment.
|Condition or disease||Intervention/treatment||Phase|
|Ewing Sarcoma Rhabdomyosarcoma Wilms Tumor Neuroblastoma Hepatoblastoma Germ Cell Tumor||Drug: Vorinostat||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Vorinostat in Combination With Vincristine, Irinotecan, and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors and CNS Malignancies|
|Actual Study Start Date :||March 17, 2017|
|Estimated Primary Completion Date :||December 17, 2021|
|Estimated Study Completion Date :||December 17, 2022|
The first cycle of chemotherapy will not include the experimental agent vorinostat. This first cycle will be used to determine whether the patient can tolerate the chemotherapeutic backbone without developing a DLT.
This is a phase I study of the combination of four drugs: vorinostat, vincristine, irinotecan, and temozolomide. This is called a Phase I study because the goal is to find the highest dose of vorinostat that investigators can give safely when it is used together with the chemotherapy drugs vincristine, irinotecan and temozolomide. Investigators are using vorinostat because it seems to work against cancer in test tubes and animals. It may be most effective when it is given with chemotherapy. The combination of these three agents together has never been given to children. Vincristine, irinotecan, and temozolomide are approved and used for the treatment of other types of cancer in adults and children. Vorinostat is approved and used to treat cancer in adults. The combination of these four drugs together is experimental. Investigators do not know if this combination of medicines will work in people. There is a lot that investigators do not yet know about this combination of medicines.
Other Name: Zolinza
- To determine a maximally tolerated (or optimal) dose of vorinostat [ Time Frame: 1 year ]A minimum of 3 evaluable patients will be entered at each dose level. If no significant dose limiting toxicity is discovered, a maximum of 3 dose levels will be evaluated. The minimum patient enrollment will be 3 patients. Many of the patients enrolled on this trial are expected to be heavily pretreated. All patients will be given a VIT only "window" to evaluate adequate bone marrow reserve to tolerate protocol therapy. We expect that at most 20% of patients will not be able to tolerate VIT or VIT with dose reduced temozolomide. A maximum of 24 patients enrolled on study is anticipated. Once the MTD has been defined, up to 6 additional patients may be enrolled to acquire additional safety data regarding this combination of agents.
- Overall response rate (ORR) after therapy [ Time Frame: 1 year ]
To determine the overall response rate (ORR) of vorinostat in combination with VIT in children, adolescents, and young adults with relapsed or refractory solid tumors.
The overall (CR+PR) and best response rates with the 95% confidence intervals will be estimated based on the exact binomial distribution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308330
|Contact: Harshini Mahanti, BSfirstname.lastname@example.org|
|Contact: Lauren Harrison, MSNemail@example.com|
|United States, New York|
|New York Medical College||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Harshini Mahanti, BS|
|Principal Investigator: Jeremy Rosenblum, MD|
|Principal Investigator:||Jeremy Rosenblum, MD||New York Medical College|