Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors

Learn more about:
Related Clinical Trial
A Phase II Trial Evaluating the Efficacy of Cabozantinib With Patients With Refractory GCTs Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors A Study of a New Way to Treat Children With a Brain Tumor Called NGGCT Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults Symptom Management for YA Cancer Survivors A Study of miRNA 371 in Patients With Germ Cell Tumors Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors HER2-specific CAR T Cell Locoregional Immunotherapy for HER2-positive Recurrent/Refractory Pediatric CNS Tumors Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors Aflac ST0901 CHOANOME – Sirolimus in Solid Tumors Study of Genistein in Pediatric Oncology Patients (UVA-Gen001) A Pilot RCT of the PRISM Intervention for AYAs With Cancer Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors Molecular-Guided Therapy for Childhood Cancer EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors Auto Transplant for High Risk or Relapsed Solid or CNS Tumors Busulfan in Treating Children and Adolescents With Refractory CNS Cancer CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Haven’t Responded to Therapy ABT-751 in Treating Young Patients With Refractory Solid Tumors Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors Collecting and Storing Tissue From Young Patients With Cancer Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Everolimus in Refractory Testicular Germ Cell Cancer Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors Adolescent and Young Adult Cancer Patients: Cognitive Toxicity on Survivorship (ACTS) A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors First Line TIP in Poor Prognosis TGCTs. Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy Electroacupuncture in Treating Delayed Nausea and Vomiting in Patients Receiving Chemotherapy For Newly Diagnosed Childhood Sarcoma, Neuroblastoma, Nasopharyngeal Cancer, Germ Cell Tumors, or Hodgkin Lymphoma Disulfiram and Cisplatin in Refractory TGCTs. Role of Axumin PET Scan in Germ Cell Tumor Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors Study of the Hypomethylating Drug Guadecitabine (SGI-110) Plus Cisplatin in Relapsed Refractory Germ Cell Tumors Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors Treatment Outcome and Quality of Life in Patients With Pediatric Extra-Cranial Germ Cell Tumors Previously Treated on Clinical Trial CCLG-GC-1979-01 or CCLG-GC-1989-01 Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors Durvalumab Alone or With Tremelimumab in Refractory Germ Cell Tumors Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors Accelerated v’s Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors Salvage Chemotherapy for Poor Prognosis Germ Cell Tumors Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors Nivolumab in Platinum Recurrent or Refractory Metastatic Germ Cell Tumors Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors Germ Cell Tumor and Testicular Tumor DNA Registry A Phase II Study of Sirolimus and Erlotinib in Recurrent/Refractory Germ Cell Tumors Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors

Brief Title

Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors

Official Title

Phase II Study of Brentuximab Vedotin and Bevacizumab in Men With Refractory CD-30 Positive Germ Cell Tumors

Brief Summary

      This is a multi-center phase II study of brentuximab vedotin in combination with bevacizumab
      for the treatment of refractory CD-30+ germ cell tumors (GCT) after disease progression on
      imaging and/or tumor marker progression documented by serially rising alpha-fetoprotein (AFP)
      or beta human chorionic gonadotropin (bHCG) measured on at least 2 consecutive visits and
      determined by treating physician to be clinically significant. Patients unable to receive 2nd
      line of platinum-based chemotherapy due to toxicity or refusal would also be eligible.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.

Secondary Outcome

 Number of Participants Experiencing Progression Free Survival

Condition

Germ Cell Tumor

Intervention

Brentuximab Vedotin

Study Arms / Comparison Groups

 Brentuximab Vedotin & Bevacizumab
Description:  Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated.
Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days.

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

Drug

Estimated Enrollment

1

Start Date

March 29, 2017

Completion Date

December 15, 2019

Primary Completion Date

December 15, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Male, ≥ 18 years of age

          -  Diagnosis of CD-30 positive germ cell tumor. CD30 expression will be tested by
             immunohistochemistry (IHC) in archival or fresh tumor tissue as is routinely done for
             diagnosis.

          -  Disease progression on imaging or tumor marker progression (clinical significance of
             tumor marker progression to be decided per the discretion of treating physician) after
             at least 2 lines of platinum-based chemotherapies unless patient is ineligible for
             further platinum based chemotherapy or refuses 2nd line platinum based chemotherapy
             due to toxicity. For primary mediastinal germ cell tumors, failure of first-line
             chemotherapy will be accepted. Prior high dose chemotherapy with hematopoietic stem
             cell rescue is allowed. Prior treatment with bevacizumab is allowed.

          -  At least 3 weeks should have elapsed since the last treatment (e.g. chemotherapy,
             targeted small molecule therapy, immunotherapy or radiation) and must have recovered
             to grade 1 or better from the acute effects of prior therapy.

          -  Presence of measurable disease according to RECIST 1.1

          -  ECOG performance status 0 or 1

          -  Adequate marrow and organ function within 28 days prior to study registration as
             defined below:

               -  Leukocytes > 3,000/µL

               -  ANC > 1500/µL

               -  Hemoglobin ≥ 9 g/dL, Note: Blood transfusion will be allowed for patients with
                  hemoglobin < 9 g/dl and G-CSF is allowed for neutropenic patients at time of
                  enrollment.

               -  Platelets > 100,000/mm3

               -  Creatinine: ≤3mg/dl OR if serum creatinine > 3 mg/dl, estimated GFR >30
                  mL/min/1.73m2

               -  INR: <1.5 x institutional upper limit of normal OR < 3 if on warfarin or other
                  anticoagulants. There should be no evidence of active bleeding while on
                  anticoagulants.

               -  Total bilirubin: ≤ 2 x institutional upper limit of normal (ULN)

               -  SGOT (AST) or SGPT (ALT): < 3 x institutional upper limit of normal (< 5 x ULN if
                  liver metastases present)

               -  Proteinuria: If patient has proteinuria, it should be <2+ (< 100 mg/dl or per
                  institutional guidelines). If proteinuria is 2+ or greater (≥ 100 mg/dl per
                  institutional guidelines), patients should undergo a 24- hour urine collection
                  and 24 hour urinary protein should be less than < 2 grams.

          -  Sexually active men with partners of women of childbearing potential must agree to
             practice effective methods of contraception during the study and for 6 months after
             the last treatment

          -  Provide voluntary written consent and HIPAA authorization for release of personal
             health information, approved by an Institutional Review Board/Independent Ethics
             Committee (IRB/IEC)

        Exclusion Criteria:

          -  Prior treatment with Brentuximab Vedotin.

          -  Known active brain metastases and or carcinomatous meningitis. Subjects with
             previously treated brain metastases may participate provided brain metastases are
             stable (without evidence of progression by imaging for at least four weeks prior to
             the first dose of trial treatment and any neurologic symptoms have returned to
             baseline), have no evidence of new or enlarging brain metastases, and are not using
             steroids for at least 7 days prior to study registration. This exception does not
             include carcinomatous meningitis, which is excluded regardless of clinical stability.

          -  History of blood clots, pulmonary embolism, or deep vein thrombosis in previous 6
             months unless controlled by anticoagulant treatment

          -  Known history of HIV

          -  Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
             [qualitative] is detected)

          -  Received a live vaccine within 1 week prior to the first dose of study treatment

          -  Has active autoimmune disease that required systemic treatment with use of disease
             modifying agents, corticosteroids or immunosuppressive drugs

          -  Any clinically significant active infection that requires systemic treatment at the
             time of enrollment.

          -  Known allergy to bevacizumab or brentuximab vedotin or any of its excipients

          -  Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,
             sustained ventricular tachycardia, ventricular fibrillation, clinically significant
             bradycardia, advanced heart block or a history of acute myocardial infarction (MI)
             within 6 months of study registration

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             in previous 6 months

          -  Prior major surgery within the previous 28 days of study registration and/or presence
             of any non-healing wound, fracture, or ulcer.

          -  Use of an investigational agent within the previous 28 days of study registration.

          -  Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥150 mmHg
             and/or diastolic blood pressure (DBP) of ≥ 90mmHg]. Note: Initiation or adjustment of
             antihypertensive medication(s) is permitted prior to study registration

          -  Arterial thromboembolic events, including transient ischemic attack (TIA),
             cerebrovascular accident (CVA), unstable angina, or MI within 6 months of study
             registration

          -  History of posterior reversible encephalopathy syndrome

          -  Other malignancies unless the patient is considered to be disease-free and has
             completed therapy for the malignancy > than 6 months prior to study entry

          -  Any serious and/or unstable pre-existing medical, psychiatric, or other condition that
             could interfere with subject's safety, provision of informed consent, or compliance to
             study procedures

          -  Concurrent use of rifampin or ketoconazole
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shilpa Gupta, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02988843

Organization ID

2015LS190


Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota


Study Sponsor

Shilpa Gupta, Principal Investigator, University of Minnesota


Verification Date

November 2020