Adults are Eligible for Many Pediatric Clinical Trials

Charles Rubin, MD

Charles Rubin, MD

By Charles Rubin, MD

In a previous blog post, I pointed out the relative lack of overlap between the cancer types seen in children and adults.

However, there are plenty of examples of cancers that afflict both children and adults, most notably in the leukemias and lymphomas.

This overlap was one of the reasons behind the creation of the Adolescent and Young Adult (AYA) Oncology Program, a clinic jointly staffed by pediatric and medical oncologists.

Jennifer McNeer, MD, MS, assistant professor of pediatrics, and Wendy Stock, MD, professor of medicine, founded the clinic and are the lead oncologists.

Most clinical trials in the past had eligibility criteria that followed strictly to either pediatric or adult age ranges, such as 0-17 years, 0-21 years, or 18 year and over.

More recently, protocols have been designed to include children and adults within the same clinical trial.

The University of Chicago Medicine, for example, has a number of Phase I trials that are open to 12-year-olds and above, allowing some teenagers with refractory or recurrent tumors to take advantage of drugs that otherwise would have been inaccessible.

The Children’s Oncology Group (COG), a major NCI-funded cooperative group, also has a growing number of trials that span the age barrier.  Nearly all of the trials allow patients up to and including age 21 years, but many go beyond.

Also, there are non-therapeutic protocols to study survivors of childhood cancer and to study tumor classification and biology with no age limit.

The University of Chicago Medicine Comer Children’s Hospital is a treatment site for this group.

Similarly, the privately and NCI-funded pediatric consortium New Approaches in Neuroblastoma Therapy (NANT), allows young adults to enroll in its trials; there are 15 sites in North America, including Comer Children’s Hospital.

The principal investigator at Comer for NANT is Susan Cohn, MD, professor of pediatrics, and director, clinical research, for the Section of Pediatric Hematology/Oncology.

If the patients are not too far above the pediatric range (i.e. over  30 ) we can take care of them in our pediatric clinics and hospital.

We are currently treating a 22-year-old with metastatic neuroblastoma, a 29-year-old with Wilms tumor, and a 23-year-old with T-cell lymphoma, to name only a few of our over-21 patients.

The ability to collect data on these patients who previously were not recorded or studied will hopefully prove valuable to future patients.

Some examples of currently open clinical trials that allow pediatric and adult patients are listed below:

University of Chicago 12-1169
A Pharmacodynamic Study of Sirolimus in Older Children and Adults with Advanced Solid Malignancies. (Age 12 years and up).

COG AALL1131
A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine in the Very High Risk Stratum.  (Up to age 30 years).

COG AALL0434
Intensified Methotrexate, Nelarabine and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute LymphoblasticLeukemia (ALL) or T-cell Lymphoblastic Lymphoma.  (Up to age 30 years).

COG AAML05P1
Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Stem Cell Transplantation (SCT) for AML with Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory
and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children’s Oncology Group (COG) Study.  (Up to age 30 years).

COG AREN0532
Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor.  (Up to age 30 years).

COG AREN0534
Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor.  (Up to age 30 years).

COG ADVL1121
A Phase II Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib (IND# 69896) in Children and Young Adults with Relapsed/Refractory Rhabdomyosarcoma, Wilms Tumor, Hepatocellular Carcinoma, and Papillary Thyroid Carcinoma.  (Up to age 30 years for rhabdomyosarcoma and Wilms tumor stratum).

COG ANBL1221
A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC# 683864, IND# 61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 623408, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma.  (Any age).

COG ARST08P1
A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody,IND#100947, NSC # 742460]) in Combination with Intensive Multi-Agent Interval Compressed Therapy for Patients with High-Risk Rhabdomyosarcoma.  (Up to age 50 years).

COG AEWS1031
A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma.  (Up to age 50 years).

COG ARST0921
A Randomized Phase II Trial of Bevacizumab and Temsirolimus in Combination with Intravenous Vinorelbine and Cyclophosphamide in Patients with Recurrent/Refractory Rhabdomyosarcoma.  (Up to age 30 years).

NANT N99-02
Modulation of Intensive Melphalan (L-PAM) by Buthionine Sulfoximine (BSO) (NSC-326321) and Autologous Stem Cell Support For Recurrent High-Risk Neuroblastoma. (Age 9 months up to 30 years).

NANT N2004-04
A Phase I Study of Fenretinide Lym-X-SorbTM (LXS) Oral Powder in Patients with Recurrent or Resistant Neuroblastoma. (Up to age 30 years).

NANT N2004-05
Neuroblastoma Biology Study. (Age 1 month with no upper age limit).

NANT N2007-02
A Phase I Study Of Bevacizumab With Bolus And Metronomic Cyclophosphamide And Zoledronic Acid In Children With Recurrent Or Refractory Neuroblastoma. (Up to age 30 years).

NANT N2008-02
A Phase I Study of Vorinostat in Combination with 13-Cis-Retinoic Acid in Patients with Refractory/Recurrent Neuroblastoma. (Up to age 30 years).

NANT N2009-03
Phase I/II study of MLN8237 in combination with Irinotecan and Temozolomide for patients with relapsed or refractory Neuroblastoma. (Ages 12 months to 30 years).

More details about these trials can be found on their respective web sites:

University of Chicago Medicine clinical trials

Children’s Oncology Group

New Approaches in Neuroblastoma Therapy (NANT)

An authority on all pediatric cancers, Dr. Charles Rubin has been overseeing the care of children for more than 25 years. He is a strong believer in educating patients and their families–and in involving them in the decision process in a meaningful way. Dr. Rubin has worked to uncover the genetic basis for cancer through laboratory research aimed at identifying the chromosomal abnormalities that occur in childhood cancers. He is involved in clinical trials for childhood cancer treatments and has published numerous articles in top medical journals on leukemia, lymphoma, retinoblastoma and other diseases.

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