Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features

NCT01048892 | Completed Phase 1

• 3 other identifiers: ADVL0911COG-ADVL0911CDR0000663520
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 18

Brief Summary

RATIONALE: Seneca Valley virus-001 may be able to kill certain kinds of tumor cells without damaging normal cells. Adding low dose cyclophosphamide (in part B of study) may help to kill even more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of Seneca Valley virus-001 in treating young patients with relapsed or refractory neuroblastoma, rhabdomyosarcoma, or rare tumors with neuroendocrine features.

Conditions

Adrenocortical Carcinoma; Gastrointestinal Carcinoid Tumor; Kidney Cancer; Neuroblastoma; Retinoblastoma; Sarcoma

Keywords

recurrent neuroblastoma; previously treated childhood rhabdomyosarcoma; recurrent childhood rhabdomyosarcoma; recurrent Wilms tumor and other childhood kidney tumors; recurrent retinoblastoma; recurrent adrenocortical carcinoma; recurrent gastrointestinal carcinoid tumor

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability

  12 months post-documented viral clearance

• Recommended phase II dose of Seneca Valley virus-001 (NTX-010)

  56 days

Secondary Outcomes (3)

• Tumor response

  Up to 12 months post documented viral clearance

• Viral titers in blood and stool

  Up to 56 days post treatment

• Development of antibodies to NTX-010

  Up to 4 weeks post treatment

Study Arms (1)

Treatment (NTX-010)

EXPERIMENTAL

Biological: Seneca Valley virus-001; Drug: cyclophosphamide; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

Seneca Valley virus-001 BIOLOGICAL

Treatment (NTX-010)

cyclophosphamide DRUG

Treatment (NTX-010)

laboratory biomarker analysis OTHER

Treatment (NTX-010)

pharmacological study OTHER

Treatment (NTX-010)

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Neuroblastoma * Rhabdomyosarcoma * Wilms tumor * Retinoblastoma * Adrenocortical carcinoma * Carcinoid tumor * Relapsed or refractory disease * Measurable or evaluable disease * No known curative therapy or therapy proven to prolong survival with an acceptable quality of life * No known pulmonary tumors or metastases \> 5 cm, as evaluated by chest CT scan * No clinically significant pulmonary and/or pericardial effusions (≥ grade 3), as evaluated by ECHO * No primary CNS tumors or known metastatic CNS disease involvement PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 50-100% (for patients \> 16 years of age) * Lansky PS 50-100% (for patients ≤ 16 years of age) * Peripheral ANC ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent, defined as no platelet transfusions within a 7-day period before study enrollment) * Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed) * Creatine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows: * ≤ 0.8 mg/dL (for patients 3 to 5 years of age) * ≤ 1.0 mg/dL (for patients 6 to 9 years of age) * ≤ 1.2 mg/dL (for patients 10 to 12 years of age) * ≤ 1.4 mg/dL (for female patients ≥ 13 years of age) * ≤ 1.5 mg/dL (for male patients 13 to 15 years of age) * ≤ 1.7 mg/dL (for male patients ≥ 16 years of age) * Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 times upper limit of normal (ULN) * SGPT ≤ 110 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L) * Serum albumin ≥ 2 g/dL * Oxygen saturation \> 92% on room air * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to comply with the safety monitoring requirements of the study, in the opinion of the investigator * Completely toilet trained * No chronic diarrhea or urinary incontinence during the day or night, , and no in-dwellling urinary catheters * No uncontrolled infection * No known pregnant member of the household PRIOR CONCURRENT THERAPY: * Fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy * At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis * At least 3 months since prior stem cell transplantation or rescue (without TBI) * No evidence of active graft-vs-host disease * At least 6 weeks since other prior substantial bone marrow radiotherapy or treatment with therapeutic doses of MIBG * More than 3 weeks since prior myelosuppressive chemotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * More than 7 days since prior growth factor(s) that support platelet or white blood cell number or function * At least 7 days since prior biologic agents * At least 3 half-lives since prior monoclonal antibodies * More than 7 days since prior viral immunizations, including influenza * At least 42 days since the completion of any type of immunotherapy, e.g., tumor vaccines * No other viral immunizations after enrolling on study until 28 days after their last planned Seneca Valley virus-001 infusion or until documented viral clearance, whichever is longest * Concurrent corticosteroids allowed provided the patient has been on a stable or decreasing dose for the past 7 days * No other concurrent investigational drugs * No other concurrent anticancer agents (e.g., chemotherapy, radiotherapy, immunotherapy, or biologic therapy) * Prior treatment with Seneca Valley virus-001 is not allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60611, United States

Location

Riley's Children Cancer Center at Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 2115, United States

Location

C.S. Mott Children's Hospital at University of Michigan Medical Center

Ann Arbor, Michigan, 48109-0286, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030-2399, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Adrenocortical Carcinoma; Kidney Neoplasms; Neuroblastoma; Retinoblastoma; Sarcoma; Wilms Tumor

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Michael J. Burke, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2013
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

US (18)