Treatment with SGN-35 in patients with CD30-positive hematologic malignancies who have previously participated in an SGN-35 study
Michelle A. Fanale
The goal of this clinical research study is to study the safety of SGN-35 (also called brentuximab vedotin) for re-treating patients who have cancer that has not responded to treatment or has come back after treatment. Researchers also want to determine if re-treatment with SGN-35 can affect the tumor.
Disease Group: Lymphoma
Treatment Agent: SGN-35
Treatment Location: Both at MD Anderson & outside MD Anderson at one or more Collaborating Sites or Institutions
Estimatated Length of Stay in Houston: N/A
Sponsor: Seattle Genetics, Inc.
Return Visit: Screening, Cycle 1, Days1, 2, 4, 8, 15 & 22. Cycle 2, Days 1, 8, 15, 16, 18, 22. End of Treatment and post End of Treatment.
Home Care: N/A
Primary objectives • To assess the safety of treatment with Seattle Genetics-35 (SGN-35). • To estimate the antitumor response of retreatment with SGN-35. Secondary objectives • To assess duration of tumor control, including duration of response and progression-free survival (PFS) of retreatment with SGN-35. • To assess overall survival (OS). • To assess the incidence of anti-therapeutic antibodies (ATA).
IRB Review and Approval Date: 09/14/2009
Recruitment Status: Not Accepting
Projected Accrual: 125
1) Patients must meet all of the following inclusion criteria to be
eligible for the retreatment arm of this study. Experienced either
complete or partial remission with known SGN-35 treatment, and had
disease progression or relapse after discontinuing treatment in the
prior SGN-35 study.
2) Completed any prior treatment with radiation, chemotherapy, biologics, and/or any other investigational agents at least 4 weeks prior to the first dose of SGN-35 in this study.
3) Documentation of CD30 expression status after most recent treatment for hematologic malignancy. If tissue from the most recent post diagnostic biopsy of relapse/refractory disease is not available, a fresh biopsy should be obtained unless rebiopsy would result in unacceptable risk in the setting of potential marginal benefit.
4) Computed tomography (CT) scan within 4 weeks preceding enrollment in this study.
5) An Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
6) The following required baseline laboratory data: absolute neutrophil count (ANC) >/= 1000/mircoL, platelets >/=50,000/microL, bilirubin </= 1.5X upper limit of normal (ULN) or </= 3X ULN for patients with Gilbert’s disease, serum creatinine </= 1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 2.5X ULN.
7) Females of childbearing potential must have a negative serum or urine beta-hCG pregnancy test result within 7 days prior to the first dose of SGN-35 in this study. Females of nonchildbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
8) Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug.
9) Patients or their legally authorized representative must provide written informed consent.
10) Patients must meet ALL of the following inclusion criteria to be eligible for extension treatment in this study: Completed treatment in a prior SGN-35 study without unacceptable toxicity and experienced clinical benefit as assessed by the Investigator. Permission from the Sponsor must be granted prior to enrollment on the extension treatment arm of the study.
11) Females of childbearing potential must have a negative serum or urine beta-hCG pregnancy test result within 7 days prior to the first dose of SGN-35 in this study. Females of nonchildbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
12) Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug.
13) Patients or their legally authorized representative must provide written informed consent.
1) If a patient is positive for ANY of the following exclusion criteria,
the patient will not be eligible for retreatment in this study: Withdrew
consent to participate in any prior SGN-35 study.
2) Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
3) History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
4) Patients with acute or chronic graft-versus-host disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GvHD.
5) Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy (PML).
6) Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of SGN-35 in this study. Routine antimicrobial prophylaxis is acceptable. For HIV-positive patients, concurrent highly active antiretroviral therapy (HAART) is acceptable.
7) Current therapy with other systemic antineoplastic (with the exception of corticosteroids) or investigational agents.
8) Women who are pregnant or lactating.
9) Patients with known hypersensitivity to any excipient (trehalose, sodium citrate, or polysorbate 80) contained in the drug formulation.
10) Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
11) Patients < 100 days from allogeneic transplant.
12) Post-allogeneic transplant patients with any detectable level of cytomegalovirus (CMV) by polymerase chain reaction (PCR). Prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to first dose of study drug.
13) Prior donor lymphocyte infusion <8 weeks prior to first dose of study drug.
14) If a patient is positive for ANY of the following exclusion criteria, the patient will not be eligible for extension treatment in this study: Withdrew consent to participate in any prior SGN-35 study.
15) Unable to receive first infusion of SGN-35 in this study between 21 - 28 days of last dose in the prior study, unless a dosing delay of up to 3 weeks is warranted for toxicity.
16) Current therapy with other systemic antineoplastic (with the exception of corticosteroids) or investigational agents.
17) Women who are pregnant or lactating.
18) Patients with a known hypersensitivity to any excipient contained in the drug formulation.
19) Post-allogeneic transplant patients must have documented CMV quantitation by PCR. If a patient has detectable levels of CMV, permission to enter the study must be granted by the Medical Monitor.
Information and next steps
Michelle A. Fanale
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