MDACC Study Summary 2006-0475 (Archived)

Study Summary
No. 2006-0475:.......Lymphoma......Anas Younes......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2006-0475

Study Title:	A Phase I Dose Escalation Study of SGN-35 in Patients with Relapsed/Refractory CD30-Positive Hematologic Malignancies.

Physician

New Patient Referral



Name:	Anas Younes	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Patients will return to clinic weekly while receiving study drug.

Treatment Agents:	SGN-35	Home Care:	none

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	none

Description/
Intervention:

The goal of this clinical research study is to find the highest tolerable dose
of SGN-35 that can be given to patients with cancer that has recurred or is
refractory.

Researchers will study the pharmacokinetics (PKs) of SGN-35. PK testing looks
at how a drug acts in the body over time, including how it is absorbed into the
body, how it moves throughout the body, and how the body gets rid of it.
Researchers will also study the effectiveness and safety of this drug.

Study Objectives / Outcomes

The primary objectives of this Phase I study are:

Define the safety profile of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.
Determine the MTD of SGN-35 administered every 21 days in patients with relapsed/refractory CD30-positive hematologic malignancies.

The secondary objectives of this study are:

Determine the PK parameters for SGN-35 and MMAE in patients with relapsed/refractory CD30-positive hematologic malignancies. PK parameters include maximum concentration (Cmax), area under the time-concentration curve (AUC), and half-life (t½); and will be estimated by using noncompartmental analysis (NCA).
Determine the immunogenicity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.
Assess antitumor response in patients with relapsed/refractory CD30-positive hematologic malignancies.

Study Status Information



Study Activation / Registration Date:	12/04/2006

IRB Review and Approval Date:	10/18/2006

Study Type:	Phase I

Recruitment Status:	Terminated

Projected Accrual:	51

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient must have a histologically confirmed CD30-positive hematologic malignancy. Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease. Tissue must be available to Seattle Genetics for confirmation of CD30 expression. Anaplastic lymphoma kinase (ALK) status must be documented for ALCL patients.

2) Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible, refused treatment by or previously received stem cell transplant. Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.

3) Patients must have measurable disease of at least 10 mm as documented by radiographic technique.

4) Patients must have completed (and recovered from treatment-related toxicities) any prior treatment with radiotherapy, chemotherapy, biologics, immunotherapy and/or treatment with other investigational anti-cancer agents at least 4 weeks prior to first study dose.

5) Patients must have completed any prior treatment with nitrogen mustard agents, melphalan, or BCNU therapy at least 6 weeks prior to first study dose.

6) Patients must have received any prior autologous hematopoietic stem cell infusion at least 8 weeks prior to first study dose.

7) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

8) Patients must be >/= 18 years of age.

9) Patient must have the following required baseline laboratory data: a) Absolute neutrophil count >/= 1,500/microL. b) Platelet count >/= 75,000/microL. c) Serum bilirubin level </= 1.5 x upper limits of normal (ULN). d) Serum creatinine </= 1.5 x ULN. e) Alanine aminotransferase [ALT or SGPT] and aspartate aminotransferase [AST or SGOT] </= 2.5 x ULN.

10) Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution and be willing to comply with the expected drug administration schedule.

11) Females of childbearing potential must have a negative serum or urine beta-hCG pregnancy test result within 3 days prior to the first dose of SGN-35 and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug. (Females of non-child-bearing potential are those who are postmenopausal >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 course of the study and for 6 months following the last dose of study drug. (Effective contraceptive methods include intrauterine devices, birth control pills, and vasectomy; additional effective methods include latex condom, diaphragm, cervical cap, or continual abstinence.)

13) Patients or their legally authorized representative must provide written informed consent.

Exclusion Criteria:

1) Patients with current diagnosis of primary cutaneous ALCL. (Patients who have transformed to systemic ALCL are eligible).

2) Patients with history of allogeneic stem cell transplant.

3) Patients who have had previous treatment with any anti-CD30 antibody.

4) Patients who have used therapeutic mAbs within 6 weeks or 5 plasma half-lives, whichever is longer.

5) Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias, if this would, in the opinion of the Investigator or Medical Monitor, interfere with assessment of efficacy or safety of the drug.

6) Patients are excluded if they have been designated Class III or IV by the New York Heart Association (NYHA) criteria.

7) Patients with a 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 with nondetectable PSA, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)

8) Patients with known cerebral/meningeal disease.

9) Patients with history of cirrhosis.

10) Patients with any active systemic viral, bacterial, or fungal infection requiring IV antibiotics within four weeks prior to first study dose.

11) Patients using concurrent therapy with other anti-neoplastic agents or experimental agents.

12) Patients using concurrent therapy with corticosteroids at >/= 12 mg/day prednisone or equivalent.

13) Patients with any serious underlying medical condition that, in the opinion of the Investigator or Medical Monitor, would impair their ability to receive or tolerate the planned treatment.

14) Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.

15) Patients with dementia or an altered mental status that would preclude the understanding and rendering of informed consent.

Links

Registration Number: NCT00430846
Study Information on Clinical Trials Registry (clinicaltrials.gov)