Merkezi Sinir Sistemi Dışı (Non-CNS) Solid Tümörleri Olan Hastalarda HSV1716

Sade dilde özet

Bu çalışma, HSV1716 adlı bir onkolitik virüs tedavisini, merkezi sinir sistemi dışında solid (katı) tümörleri olan hastalarda inceliyor. Çalışmaya, standart tedaviye dirençli tümörü olan 7-30 yaş arası hastalar alınmış ve ilaç ya doğrudan tümör içine ya da damar yoluyla uygulanmıştır. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Timothy Cripe

Müdahale

HSV1716

Başlangıç

01.03.2010

Tahmini bitiş

19.03.2018

Ülkeler

United States

İlgili genler

Merkezler

• Columbus, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

Inclusion of Women and Minorities: The study is open to all participants regardless of gender or ethnicity.

Inclusion for intratumoral injection: Subject must have 1-3 lesions amenable to HSV1716 administration by needle if superficial; by needle and/or catheter if deep or pulmonary, via interventional radiology without undue risk. Lesion(s) must meet size criteria specified in section 4.4.9.

Inclusion for intravenous administration: Subject must have metastatic disease or a lesion not deemed suitable for direct injection.

* Age: Subjects must be greater than or equal to 7 years and less than or equal to 30 years of age at the time of signing consent (study entry);
* Histologic Diagnosis: Subjects must have had histologic verification a non-CNS solid tumor at original diagnosis. The tumor must be amenable to HSV1716 administration without undue risk. Disease must be considered refractory to conventional therapy or for which no conventional therapy exists.
* Metastatic Disease: Subjects who have metastasis to the brain are eligible for the intratumoral arm of this study; however, no metastatic sites within the brain will be considered for injection. Subjects who have metastasis to the brain are eligible for the intravenous arm of this study only if those metastases have been treated and are no longer active.
* Performance Level: Karnofsky greater than or equal to 50. Subjects 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.
* Subjects must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study;
* Myelosuppressive chemotherapy: Must not have received within 28 days of entry onto this study (42 days if prior nitrosourea) accompanied by hematopoietic recovery, or 14 days of stopping non-myelosuppressive therapy as long as hematopoietic requirements are met;
* Biologic (anti-neoplastic agent): Must not have received within 7 days of entry onto this study (21 days if prior VEGF-Trap and at least 3 half-lives after last dose of a monoclonal antibody). For biologic 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;
* No Radiation Therapy greater than or equal to 14 days for local palliative XRT (small port): greater than or equal to 6 months must have elapsed if prior craniospinal XRT or if greater than or equal to 50% radiation of pelvis; greater than or equal to 42 days must have elapsed if other substantial bone marrow radiation;
* Immunoablative or myeloablative Stem Cell Transplant (SCT): greater than or equal to 6 months must have elapsed from prior autologous transplant. Subjects must not have graft versus host disease post autologous transplant;
* Investigational agent: greater than or equal to 28 days must have elapsed from treatment with a different phase I agent;
* Subjects with seizure disorder may be enrolled if on anticonvulsants and well controlled.
* At the time of enrollment, specified CNS conditions must be less than or equal to Grade II toxicity per CTCAE 3.0 criteria;
* All subjects must have adequate blood counts defined as: peripheral absolute neutrophil count (ANC) greater than or equal to 750/uL, Platelet count greater than or equal to 100,000/uL (may be a post transfusion value), Hemoglobin greater than or equal to 9.0 gm/dL (may be a post transfusion value)
* Adequate renal function defined as:Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) for age or creatinine clearance or radioisotope GFR greater than or equal to 70 ml/min/1.73 m2;
* Adequate liver function defined as: Total bilirubin less than or equal to 2.0 x ULN for age, and SGPT (ALT) less than or equal to 2.5 x ULN for age and albumin greater than or equal to 2g/dL, GGT \< 2.5 x ULN
* Adequate cardiac function as defined by: Shortening fraction \>25% by echocardiogram or ejection fraction above the institutional lower limit of normal by MUGA, No focal wall motion abnormalities as determined by either of the above studies, EKG without evidence of ischemia or significant arrythmia
* Adequate coagulation as defined by:PT/INR and PTT \<1.5 x ULN for age;
* Infectious Disease: Documented evidence of negative tests for the presence of Hepatitis B surface antigen, Hepatitis C antibody, HIV1 and HIV2 antibodies within the three months preceding study entry. Subjects who do not have such evidence must undergo appropriate testing prior to virus administration;

Exclusion Criteria:

* Stem cell transplant: No subjects who have received an allogeneic hematopoietic stem cell transplant are eligible;
* Pregnancy or Breast-Feeding: There is no available information regarding human fetal or teratogenic toxicities. Pregnant women are excluded and pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method from the time of study entry to a period of no less than four months post the final HSV1716 injection. For the same period of time, women who participate in this study must agree not to breast feed;
* Consent: Unable or unwilling to give voluntary informed consent / assent;
* Leukemia: Subjects with leukemia are not eligible for study participation;
* Infection or any other severe systemic disease or medical or surgical condition deemed significant by the principal investigator;
* Administration of any unlicensed or investigational agent within 4 weeks of entry to the study;
* Growth factor(s): No PEG-GCSF within 14 days of virus injection (day 0);
* Anti-HSV antivirals: Subjects whose physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from 2 days prior to the injection to 28 days following the injection should not be in the study.
* Subjects who have other conditions which in the opinion of the investigator contra-indicate the receipt of HSV1716 or indicate subject's inability to follow protocol requirements.