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Showing 1 - 10 of 36 Trials

ARST1921: A Safety, Pharmacokinetic and Efficacy Study of a γ-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375),in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT04195399

Population:

Pediatrics

Phase:

II

This is a Phase 2 study of a new cancer fighting drug called Nirogacestat in children and adolescents with relapsed desmoid tumor that cannot be completely removed by surgery. All patients will receive Nirogacestat by mouth twice a day at a dose of 90 mg/m2 (maximum per dose 150 mg). The overall goals of this study are to find out what effects, good and/or bad, Nirogacestat has on children and adolescents with desmoid tumors as well as how well it works in treating desmoid tumor. In addition, we want to see how the body of a child or adolescent processes the drug. Are you Eligible? (Inclusion...
T2012-002: A Pilot Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination with UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults with Relapse of Acute Lymphoblastic LeukemiaIND 128316

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT02879643

Population:

Pediatrics

Phase:

I

This is a Phase 1 multicenter study of Vincristine Sulfate Liposome Injection (Marqibo) in combination with standard chemotherapy drugs. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with acute lymphoblastic leukemia (ALL) which has come back after treatment. The purpose of this study is to evaluate the side effects of giving Marqibo with other standard chemotherapy drugs in children with relapsed ALL. Another goal is to measure how effective Marqibo given with other...
A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patient with relapsed/refractory solid tumors or lymphoma

Contact Number:

(212) 342-5162

NCT Number:

NCT03458728

Population:

Pediatrics

Phase:

I/II

The purpose of this study is to find out the effects and safety of an investigational (experimental) new drug called copanlisib in pediatric patients from 6 months to ≤ 21 years of age. This study consists in two phase, Phase I part will determine which is the right dose of copanlisib to be used in children/adolescents/adults with relapsed (has returned) or refractory (did not respond to standard treatment) solid tumor or lymphoma. Phase II part will further evaluate the effects and safety in pediatric patients with relapsed or refractory neuroblastoma, ostesarcoma, rhabdomyosarcoma and...
ARST1431 - A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR)

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02567435

Population:

Pediatrics

Phase:

III

This randomized phase III trial is studying how well standard chemotherapy (vincristine, dactinomycin, cyclophosphamide, and irinotecan) works compared to combination chemotherapy combined with temsirolimus (new agent) in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle) in patients with intermediate risk rhabdomyosarcoma. Are you Eligible? (Inclusion Criteria) Less than 21 years old at the time of study entry. Newly diagnosed with intermediate risk rhabdomyosarcoma. Patients can not have received any chemotherapy (excluding steroids) and/or...
ANBL1232: Utilizing Response and Biology Risk Factors to guide Therapy in Patients with Non-Risks Neuroblastoma

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02176967

Population:

Pediatrics

Phase:

III

This phase III study is looking at whether using certain risk factors and biomarkers (proteins and/or gene changes in tumor cells) to determine how much treatment a younger patient with non-high risk neuroblastoma should receive will allow for a decrease in treatment for these patients while still curing their neuroblastoma. For some patients, this may include no treatment and only close observation. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. This may help to avoid some of the risks and side effects related to...
ANBL1531, A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or AlK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03126916

Population:

Pediatrics/Adult

Phase:

III

This randomized clinical trial is examining whether the addition of radio- labelled MIBG or Crizotinib will improve the survival of high risk Neuroblastoma patients, as compared to standard treatment. Patients will be non-randomly assigned to Crizotinib based on tumor testing. All other patients will be randomized to receive standard therapy or standard therapy + MIBG. Are you Eligible? (Inclusion Criteria) Between 1 and 30 years of age Have a diagnosis of High Risk Neuroblastoma Enrolled on ANBL00B1 Patients must also meet all other eligibility criteria as outlined in the study
Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Chemotherapy for Hematopoietic Stem Cell Transplant Conditioning

Principal Investigator:

Diane Marie George, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03118986

Population:

Pediatrics

Phase:

II

This research study is done to find out whether adding Olanzapine to standard antiemetics will be helpful in controlling chemotherapy-induced vomiting (CINV) in children ages 2.5 to less than 17 receiving high dose cyclophosphamide for Blood/Bone Marrow Transplant (BMT) conditioning. To find this out, some of the participants in this study will receive Olanzapine and others will receive a placebo (a substance that looks like Olanzapine but does not have any active or medicinal ingredients). This will allow the researchers to compare treatment of Chemotherapy Induced Vomiting with and without...
A Phase I study examining the feasibility of intermittent convection-enhanced delivery (CED) of MTX110 for the treatment of children with newly diagnosed diffuse midline gliomas

Contact Number:

(212) 342-5162

NCT Number:

NCT04264143

Population:

Pediatrics

Phase:

I

The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor over 9-11 days. This is called a cycle chemotherapy and will be repeated one more time. The reason of using an experimental method of directly infusing the drug into the tumor is because the blood brain barrier (BBB) disallows drugs from successfully reaching the target...
AAML1531: Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02521493

Population:

Pediatrics

Phase:

III

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid...
A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Contact Number:

(212) 342-5162

NCT Number:

NCT02332668

Population:

Pediatrics

Phase:

I/II

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have either advanced melanoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL) or advanced, relapsed or refractory programmed cell death ligand 1 (PD-L1) positive malignant solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. This study is being sponsored by the Children's...

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