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COG ADVL0912 OPEN Registration Worksheet NCT00939770 Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A54DD196-B288-B398-E040-BB89AD432E23

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A54DD196-B288-B398-E040-BB89AD432E23

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  1. 8/26/12
  2. 9/24/15
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September 24, 2015

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Creative Commons BY-NC 3.0 Legacy
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Registration Brain and Central Nervous System Tumors COG ADVL0912 NCT00939770

No Instruction available.

  1. StudyEvent: COG ADVL0912 OPEN Registration Worksheet
    1. No Instruction available.
Stratification
ADVL0912 Stratum
Patient Criteria
Were tests to determine eligibility performed during the indicated period (Indicated period refers to prior to enrollment. - - Note: All studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Please see section 4.0 of the protocol for instructions on required repeated eligibility studies if more than 7 calendar days elapse between labs and start of therapy. - )
Was the patient in the indicated age range at time of study enrollment (To be eligible, patient must be greater than 12 months and less than or equal to 21 years of age at the time of study enrollment.)
Does patient have a BSA (body surface area) greater than or equal to the indicated value (BSA Dose Level 0 and 1 only: To be eligible, patients must have a BSA >= 0.4 at the time of study enrollment. - )
m2
Does patient have histologic verification of the malignancy at the indicated time point (Indicated time point refers to original diagnosis or relapse. - - To be eligible, patient must have histologic verification of malignancy at original diagnosis or relapse. - - Patients with relapsed or refractory solid tumors, CNS tumors or anaplastic large cell lymphoma excluding patients with primary cutaneous ALCL. - - Please note: The requirement for histologic verification does not apply to patients with diffuse intrinsic brain stem tumors, optic pathway tumors, or patients with pineal region tumors with elevations of serum or CSF tumor markers e.g., alpha-fetoprotein or beta-HCG.)
Does patient have neuroblastoma
Does patient have ALCL (anaplastic large cell lymphoma)
Does patient have histologic verification of the malignancy at the indicated time point (For patients with ALK fusion proteins, ALK mutations or ALK amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. - - Indicated time point refers to original diagnosis or relapse. - - Patients must have had histologic verification of malignancy at original diagnosis or relapse. - - To be eligible, patients must have confirmed ALK protein, mutations and/or amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. Testing for eligibility purposes must be performed as a CLIA certified assay.)
Did patient have ALK molecular abnormality verified by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (For patients with ALK fusion proteins, ALK mutations, or ALK amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. - - To be eligible, patients must have confirmed ALK protein, mutation and/or amplification. Testing for eligibility purposes must be performed as a CLIA certified assay. )
Does patient have histologic verification of the malignancy at the indicated time point (For Part A3 patients - - Indicated time point refers to original diagnosis or relapse. - - To be eligible, patient must have histologic verification of malignancy at original diagnosis or relapse. - - To be eligible, patients must have relapsed or refractory neuroblastoma, with or without bone marrow involvement, who are not eligible for Part A1 or A2 or cannot enroll on Part A1 because of Part suspension or lack of available slots. These patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling.)
Does patient meet the disease status requirement
Is patient's current disease state one for which there is no known curative therapy available or therapy proven to prolong survival with an acceptable quality of life (To be eligible, patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.)
Karnofsky Performance Status Score (To be eligible, patients greater than 16 years of age must have a Karnofsky performance score greater than or equal to 50. - - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I)
Lansky Performance Status Score (To be eligible, patients less than or equal to 16 years of age must have a Lansky play score greater than or equal to 50. - - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I - )
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study (- Myelosuppressive chemotherapy: Solid Tumors: Patients with solid tumors must not have received within 3 weeks of enrollment onto this study 6 weeks if prior nitrosourea. - Lymphoma: Patients with lymphoma who relapse during standard maintenance therapy are eligible at time of relapse. For patients with ALCL who relapse while they are receiving cytotoxic therapy, at least 14 days must have elapsed since the completion of cytotoxic therapy. Note: Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of PF-02341066. - - - Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. - - - Biologic anti-neoplastic agent: At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair. - - - Monoclonal antibodies: At least 7 days or 3 half-lives, whichever is longer, must have elapsed since prior treatment with a monoclonal antibody. - - - XRT: >= 2 wks for local palliative XRT small port; >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG; >= 6 months must have elapsed if prior TBI, craniospinal XRT or >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial BM radiation. - - - Bone Marrow/Stem Cell Transplant or Rescue without TBI: - - Part A1 or Part C: No evidence of active graft vs. host disease and >= 3 months must have elapsed since stem cell transplant or infusion. - - Part A2, Part A3, or Part B: No evidence of active graft vs. host disease and >= 6 weeks must have elapsed since stem cell transplant or infusion. - - )
Prior therapy type
Did patient receive nitrosourea (If prior therapy was myelosuppressive chemotherapy - - To be eligible, patients with solid tumors must not have received within 6 weeks of enrollment onto this study if prior nitrosourea.)
Has patient previously received any of the indicated agents (To be eligible, patients must not have received prior therapy with PF-02341066.)
Organ Function - Hematological
Does patient have bone marrow involvement
Does patient have adequate bone marrow function?
%
%
Were transfusions given
Organ Function - Non Hematological
Does patient have adequate renal function?
mg/dL
mL/Min/1.73m2
Does patient have adequate liver function?
mg/dL
mg/dL
Is patient able to swallow capsules or a liquid suspension
Exclusion Criteria
Pregnancy test done
Is patient pregnant
Is patient nursing
Has patient agreed to use an effective contraceptive method
Is the patient receiving corticosteroids?
Has patient been on a stable or decreasing dose of corticosteroids for the indicated period
Is patient currently receiving any other anticancer or experimental drug therapy
Does patient have an uncontrolled infection?
Is patient, in the opinion of the investigator, able to comply with the safety monitoring requirements of the study
Is patient receiving CYP3A4 substrates with narrow therapeutic indices
Did patient receive CYP3A4 inhibitor during the indicated period
Did patient receive CYP3A4 inducer during the indicated period
Consent For Research Studies
Was consent signed for Pharmacokinetics
Does the participant agree to participate in the pharmacogenetics study associated with this protocol
Patient consents to tissue submission
Patient consents to blood submission