Ipilimumab and Local Radiation Therapy in Treating Patients With Recurrent Melanoma, Non-Hodgkin Lymphoma, Colon, or Rectal Cancer

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CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

Ipilimumab and Local Radiation Therapy in Treating Patients With Recurrent Melanoma, Non-Hodgkin Lymphoma, Colon, or Rectal Cancer

Official Title

A PHASE I/II STUDY OF INTRATUMORAL INJECTION OF IPILIMUMAB IN COMBINATION WITH LOCAL RADIATION IN MELANOMA, NON-HODGKIN LYMPHOMA AND COLORECTAL CARCINOMA

Brief Summary

      This pilot phase I/II trial studies the side effects and best of dose ipilimumab when given
      together with local radiation therapy and to see how well it works in treating patients with
      recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies,
      such as ipilimumab, can block cancer growth in different ways. Some block the ability of
      cancer cells to grow and spread. Others find cancer cells and help kill them or carry
      cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer
      cells. Giving monoclonal antibody therapy together with radiation therapy may be an effective
      treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer
    

Detailed Description

      PRIMARY OBJECTIVES:

      1. To assess the safety of combining intratumoral anti-cytotoxic T-lymphocyte-associated
      protein 4 (CTLA4) immunotherapy with local radiation therapy in patients with melanoma,
      non-Hodgkin lymphoma, and colorectal carcinoma with a monotherapy ipilimumab safety lead-in.

      SECONDARY OBJECTIVES:

        1. To assess the induction of an anti-tumor immune responses using laboratory correlative
           studies.

        2. To determine tumor response rates and duration of response at unirradiated tumor sites
           in patients with advanced malignancies.

        3. To identify putative immunologic biomarkers of tumor response.

      OUTLINE: This is a phase I dose-escalation study of ipilimumab, followed by a phase 2 study.
      Only a few subjects participated in the phase 1 portion of this study. The phase 2 portion of
      this study was not conducted.

      Patients receive ipilimumab intratumorally on day 1 and undergo local radiation therapy
      within 48 hours for at least 3 fractions.

      After completion of study treatment, patients are followed up at 4 and 8 weeks, and then
      every 24 weeks for 5 years.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Dose-limiting Toxicity

Secondary Outcome

 Immune Response (Phase 2 Only)

Condition

Adult Nasal Type Extranodal NK/T-cell Lymphoma

Intervention

Ipilimumab

Study Arms / Comparison Groups

 Ipilimumab 25 mg
Description:  Participants receive ipilimumab intratumorally on Day 1

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

3

Start Date

February 2013

Completion Date

June 2015

Primary Completion Date

November 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Willing and able to give written informed consent

               -  Before any study procedures are performed, subjects (or their legally acceptable
                  representatives) will have the details of the study described to them, and they
                  will be given a written informed consent document to read; then, if subjects
                  consent to participate in the study, they will indicate that consent by signing
                  and dating the informed consent document in the presence of study personnel

          -  Histologically confirmed malignancy

               -  In Phase 1, histologically confirmed melanoma.

               -  In Phase 2, histologically confirmed melanoma, non-Hodgkin lymphoma, or
                  colorectal carcinoma

          -  Must have failed at least one systemic therapy or be intolerant to at least one prior
             systemic treatment

          -  Must have at least two lesions of evaluable size by modified World Health Organization
             (mWHO)/Cheson criteria; one of two lesions must be amenable to biopsy (core or fine
             needle aspirate) and intratumoral injection of up to 5ml (diameter >= 10mm)

          -  Subjects with asymptomatic brain metastases are eligible; (systemic steroids should be
             avoided if possible, or the subject should be stable on the lowest clinically
             effective dose, as steroids as they may interfere with the activity of ipilimumab if
             administered at the time of the first ipilimumab dose)

          -  Must be at least 28 days since treatment with standard or investigational
             chemotherapy, biochemotherapy, surgery, radiation, cytokine therapy, or immunotherapy,
             and recovered from any clinically significant toxicity experienced during treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Life expectancy of >= 16 weeks

          -  Subjects must have baseline (screening/baseline) radiographic images, (e.g. brain,
             chest, abdomen, pelvis, and bone scans with specific imaging tests to be determined by
             the attending physician) within 6 weeks of initiation of ipilimumab

          -  White blood cell (WBC) >= 2000/uL (~2 x 10^9/L)

          -  Absolute neutrophil count (ANC) >= 1000/uL (~0.5 x 10^9/L)

          -  Platelets >= 75 x 10^3/uL (~75 x 10^9/L)

          -  Hemoglobin >= 9 g/dL (may be transfused)

          -  Creatinine =< 2.0 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN for
             subjects without liver metastasis =< 5 times for liver metastases

          -  Bilirubin =< 2.0 x ULN (except for subjects with Gilbert's syndrome, who must have a
             total bilirubin of less than 3.0 mg/dL)

          -  No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B,
             or hepatitis C

          -  Women of childbearing potential (WOCBP) must be using an adequate method of
             contraception to avoid pregnancy throughout the study and for up to 26 weeks after the
             last dose of investigational product, in such a manner that the risk of pregnancy is
             minimized; WOCBP include any female who has experienced menarche and who has not
             undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
             or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:

               -  Amenorrhea >= 12 consecutive months without another cause, or

               -  For women with irregular menstrual periods and taking hormone replacement therapy
                  (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL

          -  Women who are using oral contraceptives, other hormonal contraceptives (vaginal
             products, skin patches, or implanted or injectable products), or mechanical products
             such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to
             prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg,
             vasectomy) should be considered to be of childbearing potential; WOCBP must have a
             negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent
             units of human chorionic gonadotropin [HCG]) within 72 hours before the start of
             ipilimumab

          -  Men of fathering potential must be using an adequate method of contraception to avoid
             conception throughout the study (and for up to 26 weeks after the last dose of
             investigational product) in such a manner that the risk of pregnancy is minimized

        Exclusion Criteria:

          -  Any other malignancy from which the patient has been disease-free for less than 5
             years, with the exception of adequately treated and cured basal or squamous cell skin
             cancer, superficial bladder cancer or carcinoma in situ of the cervix

          -  Autoimmune disease: patients with a history of inflammatory bowel disease, including
             ulcerative colitis and Crohn's disease, are excluded from this study, as are patients
             with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive
             sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg,
             Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g.
             Guillain-Barre Syndrome and Myasthenia Gravis)

          -  Any underlying medical or psychiatric condition, which in the opinion of the
             investigator will make the administration of ipilimumab hazardous or obscure the
             interpretation of adverse events (AEs), such as a condition associated with frequent
             diarrhea

          -  Patients with underlying heart conditions who are deemed ineligible for surgery by
             cardiology consult

          -  Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to
             1 month before or after any dose of ipilimumab)

          -  A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4
             inhibitor or agonist

          -  Concomitant therapy with any of the following: interleukin-2 (IL 2), interferon, or
             other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive
             agents; other investigation therapies; or chronic use of systemic corticosteroids

               -  A history of AEs with prior IL-2 or Interferon will not preclude subjects from
                  entering the current study

          -  Any investigational agents

          -  Immunosuppressive agents (unless required for treating potential AEs)

          -  Chronic systemic corticosteroids (unless required for treating treatment emergent AEs
             or required for management of signs or symptoms due to brain metastases, upon
             discussion with Bristol-Myers Squibb [BMS] medical monitor)

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
             treatment of either a psychiatric or physical (eg, infectious) illness

          -  Women of childbearing potential (WOCBP) who:

               -  Are unwilling or unable to use an acceptable method of contraception to avoid
                  pregnancy for their entire study period and for at least 8 weeks after cessation
                  of study drug, or

               -  Have a positive pregnancy test at baseline, or

               -  Are pregnant or breastfeeding

          -  Persons of reproductive potential must agree to use an adequate method of
             contraception throughout treatment and for at least 8 weeks after ipilimumab is
             stopped; sexually active WOCBP must use an effective method of birth control during
             the course of the study, in a manner such that risk of failure is minimized; before
             study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during
             study participation and the potential risk factors for an unintentional pregnancy; all
             WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the
             pregnancy test is positive, the patient must not receive ipilimumab and must not be
             enrolled in the study
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

George A. Fisher, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01769222

Organization ID

IRB-25597

Secondary IDs

NCI-2012-02988

Responsible Party

Principal Investigator

Study Sponsor

Stanford University

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

George A. Fisher, MD, PhD, Principal Investigator, Stanford University


Verification Date

January 2017