Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refra… (NCT01711554) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma
United States27 participantsStarted 2013-02-04
Plain-language summary
This phase I trial studies the side effects and best dose of lenalidomide when given together with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as lenalidomide and isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may interfere with the ability of tumor cells to grow and spread. Giving more than one drug (combination chemotherapy) together with dinutuximab therapy may kill more tumor cells.
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
* Patients must have high-risk neuroblastoma
* Patients must have at least ONE of the following:
* Recurrent/progressive disease at any time prior to enrollment - regardless of response to frontline therapy
* Refractory disease: persistent sites of disease (after less than a partial response to frontline therapy, following a minimum of 4 cycles of induction therapy) AND patient has never had a relapse/progression
* Persistent disease: persistent disease after achieving at least a partial response to frontline therapy after a minimum of 4 cycles of induction therapy and patient has never had a relapse/progression
* Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below):
* Bone disease
* At least one metaiodobenzylguanidine (MIBG) avid bone site or diffuse MIBG uptake
* For recurrent/progressive or refractory disease a biopsy is not required regardless of number of MIBG avid lesions
* For persistent disease, if patient has only 1 or 2 MIBG avid lesions OR a Curie score of 1-2, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at the time of enrollment (bone marrow, bone, or soft tissue) is requ…
What they're measuring
1
Maximum tolerated dose defined as the highest dose level tested at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) criteria, version 4.0